Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema (IVT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00367133
Recruitment Status : Completed
First Posted : August 22, 2006
Results First Posted : July 9, 2010
Last Update Posted : August 26, 2016
Sponsor:
Collaborators:
National Eye Institute (NEI)
Allergan
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Interventions Procedure: Standard of Care Group
Drug: 1mg triamcinolone acetonide
Drug: 4mg triamcinolone acetonide
Enrollment 840
Recruitment Details Eighty-eight academic and community based sites across the United States recruited 693 subjects from May 2004 to July 2006.
Pre-assignment Details  
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description Standard of care group: conventional treatment consisting of focal/grid photocoagulation. Intravitreal injection of 1mg of triamcinolone acetonide Intravitreal injection of 4mg of triamcinolone acetonide
Period Title: 2 Years
Started 330 [1] 256 [1] 254 [1]
Completed 272 220 205
Not Completed 58 36 49
Reason Not Completed
Death             20             12             12
Dropped             34             19             33
Missed visit             4             5             4
[1]
Number of Eyes
Period Title: 3 Years
Started 143 [1] 116 [1] 116 [1]
Completed 115 93 98
Not Completed 28 23 18
[1]
Since trial ended early, includes only those with potential for 3 year follow-up -excludes deaths
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone Total
Hide Arm/Group Description Standard of care group: conventional treatment consisting of focal/grid photocoagulation. Intravitreal injection of 1mg of triamcinolone acetonide Intravitreal injection of 4mg of triamcinolone acetonide Total of all reporting groups
Overall Number of Baseline Participants 330 256 254 840
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 330 participants 256 participants 254 participants 840 participants
63
(57 to 69)
63
(58 to 70)
63
(57 to 69)
63
(57 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 256 participants 254 participants 840 participants
Female
166
  50.3%
120
  46.9%
125
  49.2%
411
  48.9%
Male
164
  49.7%
136
  53.1%
129
  50.8%
429
  51.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 330 participants 256 participants 254 participants 840 participants
White 243 186 183 612
Black 31 22 26 79
Hispanic or Latino 39 34 33 106
Asian 7 8 5 20
American Indian/Alaskan Native 2 2 2 6
Native Hawaiian/other Pacific Islander 1 0 1 2
More than 1 race 1 1 0 2
Unknown/not reported 6 3 4 13
Diabetes Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 330 participants 256 participants 254 participants 840 participants
Type 1 14 12 12 38
Type 2 316 244 242 802
History of ocular hypertension  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 330 participants 256 participants 254 participants 840 participants
Ocular Hypertension 3 8 4 15
No Ocular Hypertension 327 248 250 825
Lens status phakic (clinical examination)  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 330 participants 256 participants 254 participants 840 participants
Phakic 262 203 197 662
Pseudophakic 68 53 57 178
OCT cystoid abnormality (questionable or definite)  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 330 participants 256 participants 254 participants 840 participants
OCT cystoid abnormality (questionable or definite) 315 243 246 804
No Evidence 12 9 6 27
Missing/can not grade 3 4 2 9
OCT subretinal fluid present (questionable or definite  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 330 participants 256 participants 254 participants 840 participants
OCT subretinal fluid present 94 64 61 219
Missing (or ungradeable) 1 4 1 6
No OCT subretinal fluid present 235 188 192 615
Prior Panretinal scatter photocoagulation  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 330 participants 256 participants 254 participants 840 participants
Prior Panretinal scatter photocoagulation 53 40 42 135
No Prior Panretinal scatter photocoagulation 277 216 212 705
Prior photocoagulation for diabetic macular edema  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 330 participants 256 participants 254 participants 840 participants
Prior photocoagulation for DME 198 154 158 510
No Prior photocoagulation for DME 132 102 96 330
Retinopathy severity (ETDRS severity scale)   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 330 participants 256 participants 254 participants 840 participants
Microaneurysms only 1 1 0 2
Mild-moderately severe nonproliferative 186 156 151 493
Severe nonproliferative 43 27 25 95
Mild to moderate proliferative 79 56 62 197
High-risk proliferative 9 8 6 23
Missing (ungradeable) 12 8 10 30
[1]
Measure Description: Early Treatment Diabetic Retinopathy Study (ETDRS) scale. Retinopathy severity data missing for: 12, 8, 10 eyes in the Laser, 1mg and 4mg treatment groups, respectively.
Visual Acuity Categorized by Randomization Strata   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 330 participants 256 participants 254 participants 840 participants
73-60 (20/32-2-20/62) 189 149 149 487
59-36 (<20/631-20/200) 129 94 92 315
35-24 (20/200-20/320) 12 13 13 38
[1]
Measure Description: Letter score and approximate Snellen equivalent. Best score is 97, worst is 0.
Central subfield thickness on OCT   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Microns
Number Analyzed 330 participants 256 participants 254 participants 840 participants
398
(329 to 505)
405
(327 to 514)
396
(323 to 484)
400
(323 to 514)
[1]
Measure Description: Mean of two baseline scans. Mean CST <250 microns based on RC grading in 15, 7, and 5 eyes for laser, 1 mg, and 4 mg groups, respectively. Missing/ungradable optical coherence tomography or fundus photo data for 1, 2, and 1 eyes for laser, 1 mg, and 4 mg groups, respectively.
Duration of Diabetes  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 330 participants 256 participants 254 participants 840 participants
15
(9 to 21)
15
(9 to 21)
16
(10 to 22)
15
(9 to 22)
HbA1c   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Percentage
Number Analyzed 330 participants 256 participants 254 participants 840 participants
7.5
(6.6 to 8.5)
7.5
(6.8 to 8.4)
7.6
(6.8 to 8.8)
7.5
(6.6 to 8.8)
[1]
Measure Description: Missing HbA1c data in 64, 46, and 50 in the laser, 1 mg, and 4 mg groups respectively
Intraocular pressure  
Median (Inter-Quartile Range)
Unit of measure:  Microns
Number Analyzed 330 participants 256 participants 254 participants 840 participants
16
(13 to 18)
16
(13 to 18)
16
(14 to 18)
16
(13 to 18)
Retinal volume on OCT   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cubic millimetre
Number Analyzed 330 participants 256 participants 254 participants 840 participants
9.2
(7.9 to 10.6)
8.9
(7.8 to 10.5)
8.9
(7.9 to 10.0)
9.0
(7.8 to 10.6)
[1]
Measure Description: Missing/ungradeable optical coherence tomography and fundus photo data for the laser, 1mg, and 4 mg groups respectively: 37, 36, 48.
e-ETDRS visual acuity   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Letter Score
Number Analyzed 330 participants 256 participants 254 participants 840 participants
62
(53 to 67)
62
(54 to 67)
62
(52 to 67)
62
(52 to 67)
[1]
Measure Description: Best corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. Best value on the scale 97, worst 0.
1.Primary Outcome
Title Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
Hide Description Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Time Frame Baseline to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis included all randomized eyes and followed the intent-to-treat principle.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 330 256 254
Mean (Standard Deviation)
Unit of Measure: Letter score
1  (17) -2  (18) -3  (22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
Comments P values for two group comparisons for difference in mean change.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANCOVA
Comments Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
Comments P Values for 2 group comparisons of difference in mean change
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
Comments P Values for 2 group comparisons of difference in mean change
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method ANCOVA
Comments Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes
2.Primary Outcome
Title Median Change in Visual Acuity Baseline to 2 Years
Hide Description Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.
Time Frame Baseline to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis included all randomized eyes and followed the intent-to-treat principle.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 330 256 254
Median (Inter-Quartile Range)
Unit of Measure: Letter score
4
(-6 to 11)
1
(-11 to 9)
2
(-11 to 11)
3.Primary Outcome
Title Distribution of Change in Visual Acuity Baseline to 2 Years
Hide Description Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
Time Frame baseline to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis included all randomized eyes and followed the intent-to-treat principle
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 330 256 254
Measure Type: Number
Unit of Measure: Percentage of Eyes
>= 15 letter improvement 18 14 17
14 to 10 letter improvement 13 11 11
9 to 5 letter improvement 16 14 15
same +- 4 letters 24 27 23
5-9 letters worse 10 9 6
10-14 letters worse 5 6 8
>=15 letters worse 14 20 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
Comments Proportion with 15-letter or more worsening
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method GEE Repeated Measures
Comments Hochberg procedure used to determine statistical significance.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
Comments Proportion with 15-letter or more worsening
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method GEE Repeated Measures
Comments Hochberg procedure used to determine statistical significance.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
Comments Proportion with 15-letter or more worsening
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method GEE Repeated Measures
Comments Hochberg procedure used to determine statistical significance.
4.Secondary Outcome
Title Central Subfield Thickness at 2 Years
Hide Description Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with an available Optical coherence tomography (OCT) at baseline and 2 years are included in the OCT analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 261 207 193
Median (Inter-Quartile Range)
Unit of Measure: Microns
243
(197 to 326)
305
(231 to 406)
279
(228 to 430)
5.Secondary Outcome
Title Mean Change in Central Subfield Thickness Baseline to 2 Years
Hide Description Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement.
Time Frame Baseline to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 261 207 193
Mean (Standard Deviation)
Unit of Measure: Microns
-139  (148) -86  (167) -77  (160)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
Comments P value not adjusted for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
Comments P Value not adjusted for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
Comments P Values not adjusted for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method ANCOVA
Comments Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.
6.Secondary Outcome
Title Median Change in Central Subfield Thickness Baseline to 2 Years
Hide Description Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Time Frame Baseline to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with an available OCT's at baseline and 2 years are included in the OCT analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 261 207 193
Median (Inter-Quartile Range)
Unit of Measure: Microns
-131
(-217 to -49)
-74
(-168 to -3)
-76
(-175 to 11)
7.Secondary Outcome
Title Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years
Hide Description Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Time Frame Baseline to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 261 207 193
Measure Type: Number
Unit of Measure: Percentage of Eyes
67 46 48
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
Comments P Values not adjusted for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method GEE Repeated Measures
Comments Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
Comments P Values not adjusted for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method GEE Repeated Measures
Comments Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
Comments P Value not adjusted for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method GEE Repeated Measures
Comments Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.
8.Secondary Outcome
Title Central Subfield Thickness < 250 Microns at 2 Years
Hide Description Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 261 207 193
Measure Type: Number
Unit of Measure: Percentage of Eyes
53 34 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 1mg Intravitreal Triamcinolone
Comments P Values not adjusted for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method GEE Repeated Measures
Comments Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Focal/Grid Laser Photocoagulation, 4 mg Intravitreal Triamcinolone
Comments P Value not adjusted for statistical analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method GEE Repeated Measures
Comments Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1mg Intravitreal Triamcinolone, 4 mg Intravitreal Triamcinolone
Comments P Value not adjusted for statistical analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method GEE Repeated Measures
Comments Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.
9.Secondary Outcome
Title Change in Visual Acuity From Baseline to 3 Years
Hide Description Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.
Time Frame Baseline to 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 115 93 98
Mean (Standard Deviation)
Unit of Measure: Letter Score
5  (17) 0  (16) 0  (21)
10.Secondary Outcome
Title Change in Visual Acuity From Baseline to 3 Years
Hide Description Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0
Time Frame Baseline to 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 115 93 98
Median (Inter-Quartile Range)
Unit of Measure: Letter Score
8
(-2 to 15)
2
(-11 to 9)
4
(-8 to 14)
11.Secondary Outcome
Title Distribution of Visual Acuity Change Baseline to 3 Years
Hide Description Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0
Time Frame Baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 115 93 98
Measure Type: Number
Unit of Measure: Percentage of Eyes
>= 15 letters better 26 20 21
10-14 letters better 18 4 16
5-9 letters better 18 17 9
no change, + - 4 letters 21 23 24
5-9 letters worse 4 10 6
10-14 letters worse 4 9 6
>=15 letters worse 8 17 16
12.Secondary Outcome
Title Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years
Hide Description Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 111 87 89
Median (Inter-Quartile Range)
Unit of Measure: Microns
211
(175 to 271)
269
(210 to 299)
248
(195 to 342)
13.Secondary Outcome
Title Change in Central Subfield Thickness on OCT Baseline to 3 Years
Hide Description Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Time Frame Baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 111 87 89
Mean (Standard Deviation)
Unit of Measure: Microns
-175  (149) -124  (184) -126  (159)
14.Secondary Outcome
Title Change in Central Subfield Thickness on OCT Baseline to 3 Years
Hide Description Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Time Frame baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 111 87 89
Median (Inter-Quartile Range)
Unit of Measure: Microns
-158
(-273 to -75)
-103
(-248 to 4)
-114
(-224 to -50)
15.Secondary Outcome
Title Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years
Hide Description Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Time Frame Baseline to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description:
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Intravitreal injection of 1mg of triamcinolone acetonide
Intravitreal injection of 4mg of triamcinolone acetonide
Overall Number of Participants Analyzed 111 87 89
Measure Type: Number
Unit of Measure: Percentage of Eyes
68 43 51
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Hide Arm/Group Description Standard of care group: conventional treatment consisting of focal/grid photocoagulation. Intravitreal injection of 1mg of triamcinolone acetonide Intravitreal injection of 4mg of triamcinolone acetonide
All-Cause Mortality
Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   135/330 (40.91%)   69/256 (26.95%)   54/254 (21.26%) 
Blood and lymphatic system disorders       
Anaemia * 1  3/330 (0.91%)  0/256 (0.00%)  2/254 (0.79%) 
Blood count abnormal * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Blood electrolytes decreased * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Blood glucose abnormal * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Blood glucose decreased * 1  2/330 (0.61%)  0/256 (0.00%)  1/254 (0.39%) 
Blood glucose increased * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Haemolytic anaemia * 1  2/330 (0.61%)  0/256 (0.00%)  1/254 (0.39%) 
Normochromic normocytic anaemia * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Cardiac disorders       
Acute myocardial infarction * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Angina unstable * 1  2/330 (0.61%)  0/256 (0.00%)  1/254 (0.39%) 
Atrial flutter * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Atrioventricular block * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Bradycardia * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Cardiac arrest * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Cardiac failure congestive * 1  18/330 (5.45%)  4/256 (1.56%)  3/254 (1.18%) 
Cardio-respiratory arrest * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Cardiomyopathy * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Coronary artery disease * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Heart rate increased * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Heart rate irregular * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Myocardial infarction * 1  16/330 (4.85%)  2/256 (0.78%)  3/254 (1.18%) 
Pulse absent * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Transient ischaemic attack * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Endocrine disorders       
Diabetes mellitus * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Diabetic coma * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Diabetic complications * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Hyperparathyroidism * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Eye disorders       
Blindness * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Cataract * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Diabetic retinopathy * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Visual acuity reduced * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Vitreous floaters * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Gastrointestinal disorders       
Crohn's disease * 1  2/330 (0.61%)  0/256 (0.00%)  2/254 (0.79%) 
Diarrhoea * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Diverticulitis * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Diverticulum * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Gastric bypass * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Gastroenteritis viral * 1  2/330 (0.61%)  0/256 (0.00%)  2/254 (0.79%) 
Gastrointestinal haemorrhage * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Gastrointestinal infection * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Gastrointestinal injury * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Impaired gastric emptying * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Lower gastrointestinal haemorrhage * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
General disorders       
Abdominal discomfort * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Abdominal hernia * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Abdominal pain * 1  4/330 (1.21%)  1/256 (0.39%)  2/254 (0.79%) 
Chest pain * 1  9/330 (2.73%)  1/256 (0.39%)  3/254 (1.18%) 
Colostomy closure * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Convulsion * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Death * 1  9/330 (2.73%)  1/256 (0.39%)  1/254 (0.39%) 
Dehydration * 1  2/330 (0.61%)  0/256 (0.00%)  2/254 (0.79%) 
Dizziness * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Fall * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Generalised oedema * 1  2/330 (0.61%)  0/256 (0.00%)  1/254 (0.39%) 
Head injury * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Headache * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Hernia * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Hyperglycaemia * 1  2/330 (0.61%)  1/256 (0.39%)  0/254 (0.00%) 
Hyperkalaemia * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Hypoglycaemia * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Hypoxia * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Intermittent claudication * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Limb injury * 1  2/330 (0.61%)  1/256 (0.39%)  1/254 (0.39%) 
oedema * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Oedema peripheral * 1  2/330 (0.61%)  2/256 (0.78%)  0/254 (0.00%) 
Pain in extremity * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Shunt malfunction * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Tobacco abuse * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Vertigo * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Hepatobiliary disorders       
Cholecystitis * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Cholecystitis acute * 1  2/330 (0.61%)  0/256 (0.00%)  2/254 (0.79%) 
Cholelithiasis * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Infections and infestations       
Erysipelas * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Localised infection * 1  5/330 (1.52%)  3/256 (1.17%)  1/254 (0.39%) 
Post procedural infection * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Pseudomonas infection * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Septic shock * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Skin bacterial infection * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Volvulus * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Wound infection staphylococcal * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Injury, poisoning and procedural complications       
Road traffic accident * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Thermal burn * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Compression fracture * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Femur fracture * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Gout * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Hip fracture * 1  5/330 (1.52%)  0/256 (0.00%)  2/254 (0.79%) 
Humerus fracture * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Intervertebral disc protrusion * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Joint swelling * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Knee arthroplasty * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Lumbar spinal stenosis * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Meniscus lesion * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Osteoarthritis * 1  2/330 (0.61%)  2/256 (0.78%)  0/254 (0.00%) 
Osteomyelitis * 1  3/330 (0.91%)  1/256 (0.39%)  1/254 (0.39%) 
Pelvic fracture * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Rib fracture * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Spinal compression fracture * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Colonoscopy abnormal * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Oesophageal carcinoma * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Prostate cancer * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Nervous system disorders       
Hydrocephalus * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Psychiatric disorders       
Dementia * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Mental disorder * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Psychotic disorder * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Vascular dementia * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Renal and urinary disorders       
Bladder transitional cell carcinoma * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Dialysis * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Kidney infection * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Nephropathy toxic * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Nephrotic syndrome * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Renal disorder * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Renal failure * 1  6/330 (1.82%)  2/256 (0.78%)  0/254 (0.00%) 
Renal failure acute * 1  3/330 (0.91%)  1/256 (0.39%)  0/254 (0.00%) 
Renal failure chronic * 1  2/330 (0.61%)  0/256 (0.00%)  1/254 (0.39%) 
Renal impairment * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Renal transplant * 1  2/330 (0.61%)  0/256 (0.00%)  1/254 (0.39%) 
Renal vessel disorder * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Urinary incontinence * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Urinary tract disorder * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Urinary tract infection * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Reproductive system and breast disorders       
Breast cancer * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
Epididymitis * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Ovarian cancer * 1  2/330 (0.61%)  2/256 (0.78%)  0/254 (0.00%) 
Ovarian cyst * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Prostate examination abnormal * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Asbestosis * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Bronchitis * 1  3/330 (0.91%)  1/256 (0.39%)  0/254 (0.00%) 
Bronchitis viral * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Dyspnoea * 1  9/330 (2.73%)  2/256 (0.78%)  2/254 (0.79%) 
Pleural effusion * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Pneumonia * 1  10/330 (3.03%)  2/256 (0.78%)  1/254 (0.39%) 
Pneumonia bacterial * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Sleep apnoea syndrome * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Skin and subcutaneous tissue disorders       
Allergy to arthropod bite * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Cellulitis * 1  4/330 (1.21%)  2/256 (0.78%)  1/254 (0.39%) 
Skin ulcer * 1  2/330 (0.61%)  1/256 (0.39%)  0/254 (0.00%) 
Surgical and medical procedures       
Limb operation * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Metatarsal excision * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Skin lesion excision * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Stent placement * 1  2/330 (0.61%)  0/256 (0.00%)  1/254 (0.39%) 
Surgical vascular shunt * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Toe amputation * 1  5/330 (1.52%)  0/256 (0.00%)  0/254 (0.00%) 
Vitrectomy * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Vascular disorders       
Angioplasty * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Arterial occlusive disease * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Arteriosclerosis coronary artery * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Carotid artery occlusion * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Cerebrovascular accident * 1  7/330 (2.12%)  2/256 (0.78%)  1/254 (0.39%) 
Coronary arterial stent insertion * 1  1/330 (0.30%)  0/256 (0.00%)  0/254 (0.00%) 
Deep vein thrombosis * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Endarterectomy * 1  1/330 (0.30%)  0/256 (0.00%)  1/254 (0.39%) 
Haematoma * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Iliac artery stenosis * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Pulmonary embolism * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Pulmonary oedema * 1  1/330 (0.30%)  1/256 (0.39%)  0/254 (0.00%) 
Rectal haemorrhage * 1  2/330 (0.61%)  0/256 (0.00%)  0/254 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Focal/Grid Laser Photocoagulation 1mg Intravitreal Triamcinolone 4 mg Intravitreal Triamcinolone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   69/330 (20.91%)   98/256 (38.28%)   163/254 (64.17%) 
Blood and lymphatic system disorders       
Anaemia * 1  21/330 (6.36%)  24/256 (9.38%)  13/254 (5.12%) 
Hypercholesterolaemia * 1  11/330 (3.33%)  6/256 (2.34%)  13/254 (5.12%) 
Cardiac disorders       
Cardiac Failure Congestive * 1  19/330 (5.76%)  17/256 (6.64%)  14/254 (5.51%) 
Hypertension * 1  17/330 (5.15%)  15/256 (5.86%)  21/254 (8.27%) 
Eye disorders       
Anterior Chamber Cell * 1  1/330 (0.30%)  14/256 (5.47%)  9/254 (3.54%) 
Cataract * 1  38/330 (11.52%)  29/256 (11.33%)  57/254 (22.44%) 
Cataract Cortical * 1  19/330 (5.76%)  22/256 (8.59%)  32/254 (12.60%) 
Cataract Nuclear * 1  13/330 (3.94%)  30/256 (11.72%)  38/254 (14.96%) 
Cataract Operation * 1  14/330 (4.24%)  16/256 (6.25%)  31/254 (12.20%) 
Cataract Subcapsular * 1  29/330 (8.79%)  54/256 (21.09%)  75/254 (29.53%) 
Conjunctival Hemorrhage * 1  7/330 (2.12%)  96/256 (37.50%)  105/254 (41.34%) 
Diabetic Retinopathy * 1  12/330 (3.64%)  13/256 (5.08%)  5/254 (1.97%) 
Dry Eye * 1  10/330 (3.03%)  13/256 (5.08%)  10/254 (3.94%) 
Eye Irritation * 1  2/330 (0.61%)  12/256 (4.69%)  15/254 (5.91%) 
Eye Pain * 1  11/330 (3.33%)  28/256 (10.94%)  33/254 (12.99%) 
Eye Pruritus * 1  9/330 (2.73%)  14/256 (5.47%)  11/254 (4.33%) 
Foreign body in the eye * 1  4/330 (1.21%)  61/256 (23.83%)  51/254 (20.08%) 
Intraocular Pressure increased * 1  14/330 (4.24%)  50/256 (19.53%)  97/254 (38.19%) 
Lacrimation increased * 1  9/330 (2.73%)  19/256 (7.42%)  16/254 (6.30%) 
Maculopathy * 1  23/330 (6.97%)  31/256 (12.11%)  31/254 (12.20%) 
Vision Blurred * 1  36/330 (10.91%)  44/256 (17.19%)  48/254 (18.90%) 
Visual acuity reduced * 1  47/330 (14.24%)  40/256 (15.63%)  51/254 (20.08%) 
Visual disturbance * 1  15/330 (4.55%)  23/256 (8.98%)  22/254 (8.66%) 
Vitreous Detachment * 1  16/330 (4.85%)  13/256 (5.08%)  7/254 (2.76%) 
Vitreous floaters * 1  36/330 (10.91%)  92/256 (35.94%)  98/254 (38.58%) 
Vitrous Hemorrhage * 1  49/330 (14.85%)  43/256 (16.80%)  32/254 (12.60%) 
General disorders       
Dysonoea * 1  15/330 (4.55%)  13/256 (5.08%)  16/254 (6.30%) 
Headache * 1  15/330 (4.55%)  11/256 (4.30%)  20/254 (7.87%) 
Oedema peripheral * 1  14/330 (4.24%)  13/256 (5.08%)  8/254 (3.15%) 
Renal and urinary disorders       
Renal failure * 1  14/330 (4.24%)  13/256 (5.08%)  8/254 (3.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Adam R. Glassman, Director DRCR.net Coordinating Center
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
Publications of Results:
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00367133     History of Changes
Other Study ID Numbers: NEI-105
U10EY018817-03 ( U.S. NIH Grant/Contract )
U10EY014229-07 ( U.S. NIH Grant/Contract )
U10EY014231-09 ( U.S. NIH Grant/Contract )
First Submitted: August 3, 2006
First Posted: August 22, 2006
Results First Submitted: July 14, 2009
Results First Posted: July 9, 2010
Last Update Posted: August 26, 2016