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Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy (LRTforDME+PRP)

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ClinicalTrials.gov Identifier: NCT00445003
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : July 13, 2011
Last Update Posted : August 26, 2016
Sponsor:
Collaborators:
National Eye Institute (NEI)
Genentech, Inc.
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, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Proliferative Diabetic Retinopathy
Diabetic Macular Edema
Interventions Drug: Ranibizumab
Drug: Triamcinolone Acetonide
Behavioral: Sham injection
Procedure: Focal/grid laser
Enrollment 333
Recruitment Details Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield >=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
Pre-assignment Details Participants with 2 study eyes enrolled each eye in a different arm. Each treatment arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description Sham injection at baseline and 4 weeks Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks 4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
Period Title: Overall Study
Started 123 113 109
Completed 118 103 105
Not Completed 5 10 4
Reason Not Completed
Death             1             2             1
Missed Visit             3             5             1
Dropped             1             3             2
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided Total
Hide Arm/Group Description Sham injection at baseline and 4 weeks Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks 4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 123 113 109 345
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 123 participants 113 participants 109 participants 345 participants
54
(45 to 61)
57
(48 to 64)
58
(49 to 64)
56
(45 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Female
44
  35.8%
48
  42.5%
44
  40.4%
136
  39.4%
Male
79
  64.2%
65
  57.5%
65
  59.6%
209
  60.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants 113 participants 109 participants 345 participants
American Indian or Alaska Native 1 0 1 2
Asian 3 1 2 6
Native Hawaiian or Other Pacific Islander 0 1 0 1
Black or African American 11 15 18 44
White 76 72 61 209
More than one race 0 0 0 0
Unknown or Not Reported 1 1 0 2
Hispanic or Latino 31 23 27 81
Optical coherence tomography subretinal fluid present (questionable or definite)   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 30 31 32 93
No 93 82 77 252
[1]
Measure Description: Based on standard reading center grading
Classification of diabetic macular edema on clinical exam  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Predominantly Focal` 37 19 27 83
Neither perdominantly focal or diffuse 18 25 14 57
Predominantly diffuse 68 69 68 205
Intraocular Pressure  
Median (Inter-Quartile Range)
Unit of measure:  mmHg
Number Analyzed 123 participants 113 participants 109 participants 345 participants
15
(13 to 18)
16
(14 to 18)
15
(13 to 18)
15
(13 to 18)
Diabetes Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Type 1 20 13 12 45
Type 2 101 93 95 289
Uncertain 2 7 2 11
Duration of diabetes  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 123 participants 113 participants 109 participants 345 participants
15
(8 to 21)
15
(10 to 21)
15
(10 to 19)
15
(8 to 21)
Hemoglobin A1c   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Percentage
Number Analyzed 123 participants 113 participants 109 participants 345 participants
7.9
(7.0 to 9.6)
8.1
(7.1 to 9.9)
8.1
(7.0 to 9.7)
8.0
(7.0 to 9.9)
[1]
Measure Description: Missing hemoglobin A1c data for study participants in the sham, ranibizumab, and triamcinolone, respectively: 4, 10, 7
Prior Cardiovascular event  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 21 35 28 84
No 102 78 81 261
Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 97 88 82 267
No 26 25 27 78
Number of study eyes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants 113 participants 109 participants 345 participants
1 study eye 97 100 96 293
2 study eyes 26 13 13 52
Prior Panretinal scatter photocoagulation  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 16 20 19 55
No 107 93 90 290
prior treatment for diabetic macular edema  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 80 75 72 227
No 43 38 37 118
Prior laser for diabetic macular edema  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 40 33 36 109
No 83 80 73 236
Prior intravitreal triamcinolone for diabetic macular edema  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 1 9 3 13
No 122 104 106 332
Prior vitrectomy for diabetic macular edema  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 2 0 0 2
No 121 113 109 343
Prior peribulbar triamcinolone for diabetic macular edema  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 1 0 1 2
No 122 113 108 343
prior anti- vascular endothelial growth factor for diabetic macular edema  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 6 1 3 10
No 117 112 106 335
Currently on intraocular pressure lowering medication for glaucoma or ocular hypertension  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 0 3 0 3
No 123 110 109 342
Lens status (clinical examination)  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Phakic 111 91 99 301
Pseudophakic 12 22 10 44
Baseline visual acuity by randomization strata   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Letter Score
Number Analyzed 123 participants 113 participants 109 participants 345 participants
67
(52 to 75)
68
(56 to 75)
67
(59 to 75)
67
(52 to 75)
[1]
Measure Description: Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Central subfield thickness on optical coherence tomography  
Median (Inter-Quartile Range)
Unit of measure:  Microns
Number Analyzed 123 participants 113 participants 109 participants 345 participants
355
(285 to 510)
352
(283 to 476)
359
(271 to 472)
355
(283 to 510)
Retinal volume on optical coherence tomography  
Median (Inter-Quartile Range)
Unit of measure:  Cubic millimetre
Number Analyzed 123 participants 113 participants 109 participants 345 participants
9.4
(8.4 to 10.6)
9.2
(8.3 to 11.0)
9.1
(8.1 to 10.0)
9.2
(8.1 to 11)
Optical coherence tomography cystoid abnormality (questionable or definite)   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Yes 108 96 96 300
No 15 17 13 45
[1]
Measure Description: From reading center grading.
Early Treatment Diabetic Retinopath Study Retinopathy severity level from photograph grading   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 123 participants 113 participants 109 participants 345 participants
Level 35, 43 (Mild/Moderate NPDR) 6 5 6 17
Level 47 (Moderately severe NPDR) 26 15 10 51
Level 53 (Severe NPDR) 5 6 5 16
Level 60 (Prior PRP without active neovascularizat 2 4 3 9
Level 61 (Mild/Moderate PDR) 48 36 38 122
Level 71, 75 (High-risk PDR) 32 43 43 118
cannot grade 4 4 4 12
[1]
Measure Description: Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833
1.Primary Outcome
Title Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks
Hide Description Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Time Frame baseline to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with 2 study eyes enrolled each eye in a different arm. Each arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. Analysis followed intention to treat principle; eyes without 14-week data, the Last Observation Carried Forward method was used.
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description:
Sham injection at baseline and 4 weeks
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
Overall Number of Participants Analyzed 123 113 109
Mean (Standard Deviation)
Unit of Measure: Letter Score
-4  (14) 1  (11) 2  (11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, 0.5mg Ranibizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
2.2 to 9.0
Estimation Comments adjusted for multiple comparison
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, 4-mg Triamcinolone Acetonided
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
3.2 to 10.1
Estimation Comments adjusted for multiple comparisons
2.Secondary Outcome
Title Additional Treatments for Diabetic Macular Edema
Hide Description Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.
Time Frame 14 weeks to 56-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description:
Sham injection at baseline and 4 weeks
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
Overall Number of Participants Analyzed 123 113 109
Measure Type: Number
Unit of Measure: Eyes
Bevacizumab 14 12 9
Ranibizumab 1 0 3
Triamcinolone 3 8 2
Pegaptanib 0 0 3
Laser 31 10 21
Vitrectomy 2 1 0
Bevacizumab plus Triamcinolone 2 0 2
Ranibizumab plus Triamcinolone 0 1 0
Bevacizumab plus laser 8 5 0
Ranibizumab plus laser 0 3 0
Triamcinolone plus laser 7 4 5
Pegaptanib plus laser 1 0 0
Triamcinolone plus vitrectomy 0 1 0
Pegaptanib plus vitrectomy 0 1 0
Triamcinolone plus laser plus vitrectomy 0 1 0
Bevacizumab plus triamcinolone plus laser 2 1 0
3.Secondary Outcome
Title Change in Optical Coherence Tomography Central Subfield Thickness
Hide Description [Not Specified]
Time Frame Baseline to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description:
Sham injection at baseline and 4 weeks
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
Overall Number of Participants Analyzed 123 113 109
Median (Inter-Quartile Range)
Unit of Measure: Microns
362
(287 to 484)
312
(259 to 453)
265
(230 to 304)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, 0.5mg Ranibizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.01
Comments Adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -35
Confidence Interval (2-Sided) 95%
-64 to -6
Estimation Comments adjusted for multiple comparisons
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, 4-mg Triamcinolone Acetonided
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -100
Confidence Interval (2-Sided) 95%
-128 to -71
Estimation Comments adjusted for multiple comparisons
4.Secondary Outcome
Title Total Optical Coherence Tomography Retinal Volume
Hide Description Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.
Time Frame Baseline to 14-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with 2 study eyes enrolled each eye in a different arm. Therefore, each arm includes no more than 1 eye for a given participant, and thus the numbers of eyes is equal to number of participants.
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description:
Sham injection at baseline and 4 weeks
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
Overall Number of Participants Analyzed 69 66 66
Mean (Standard Deviation)
Unit of Measure: mm^3
9.7  (1.8) 9.3  (1.9) 7.9  (1.0)
5.Secondary Outcome
Title Change in Visual Acuity From Baseline
Hide Description Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Time Frame baseline to 56-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description:
Sham injection at baseline and 4 weeks
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
Overall Number of Participants Analyzed 111 95 93
Mean (Standard Deviation)
Unit of Measure: Letter Score
-6  (17) -4  (21) -5  (16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, 0.5mg Ranibizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-3.7 to 7.5
Estimation Comments adjusted for multiple comparisons
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, 4-mg Triamcinolone Acetonided
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-4.4 to 6.8
Estimation Comments adjusted for multiple comparisons
6.Secondary Outcome
Title Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema
Hide Description [Not Specified]
Time Frame 14 weeks to 56-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description:
Sham injection at baseline and 4 weeks
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
Overall Number of Participants Analyzed 123 113 109
Measure Type: Number
Unit of Measure: Eyes
28 23 17
7.Secondary Outcome
Title Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema
Hide Description Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments.
Time Frame 14 weeks to 56-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description:
Sham injection at baseline and 4 weeks
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
Overall Number of Participants Analyzed 123 113 109
Measure Type: Number
Unit of Measure: Eyes
71 48 45
8.Secondary Outcome
Title Change in Optical Coherence Tomography Retinal Volume
Hide Description Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively
Time Frame Baseline to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description:
Sham injection at baseline and 4 weeks
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
Overall Number of Participants Analyzed 69 66 66
Mean (Standard Deviation)
Unit of Measure: mm^3
0.1  (1.1) -0.4  (1.3) -1.3  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.0 to -0.2
Estimation Comments adjusted for multiple comparisons
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, 4-mg Triamcinolone Acetonided
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.1 to -1.3
Estimation Comments adjusted for multiple comparisons
Time Frame Through 14-week Primary outcome visit
Adverse Event Reporting Description Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield >=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
 
Arm/Group Title Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Hide Arm/Group Description Sham injection at baseline and 4 weeks Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks 4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
All-Cause Mortality
Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/133 (8.27%)   15/116 (12.93%)   12/115 (10.43%) 
Cardiac disorders       
Angina pectoris * 1  0/133 (0.00%)  0/116 (0.00%)  1/115 (0.87%) 
Coronary artery disease * 1  0/133 (0.00%)  1/116 (0.86%)  1/115 (0.87%) 
Heart rate decreased * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
Ischaemic cardiomyopathy * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
Myocardial infarction * 1  1/133 (0.75%)  0/116 (0.00%)  0/115 (0.00%) 
Transient ischaemic attach * 1  1/133 (0.75%)  0/116 (0.00%)  1/115 (0.87%) 
Endocrine disorders       
Renal failure * 1  1/133 (0.75%)  0/116 (0.00%)  0/115 (0.00%) 
Eye disorders       
Endophthalmitis * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
Retinal detachment * 1  1/133 (0.75%)  0/116 (0.00%)  0/115 (0.00%) 
Vitreous haemorrhage * 1  1/133 (0.75%)  0/116 (0.00%)  0/115 (0.00%) 
Gastrointestinal disorders       
Cholelithiasis * 1  0/133 (0.00%)  0/116 (0.00%)  1/115 (0.87%) 
Diabetic gastroparesis * 1  1/133 (0.75%)  0/116 (0.00%)  0/115 (0.00%) 
General disorders       
Abdominal pain * 1  0/133 (0.00%)  0/116 (0.00%)  1/115 (0.87%) 
Cellulitis * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
Cerebrovascular accident * 1  1/133 (0.75%)  1/116 (0.86%)  1/115 (0.87%) 
Chest pain * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
Convulsion * 1  0/133 (0.00%)  0/116 (0.00%)  1/115 (0.87%) 
Death * 1  1/133 (0.75%)  1/116 (0.86%)  1/115 (0.87%) 
Diabetes mellitus * 1  1/133 (0.75%)  1/116 (0.86%)  0/115 (0.00%) 
Hypertension * 1  1/133 (0.75%)  0/116 (0.00%)  0/115 (0.00%) 
Ischaemic stroke * 1  0/133 (0.00%)  0/116 (0.00%)  1/115 (0.87%) 
Nausea * 1  0/133 (0.00%)  0/116 (0.00%)  1/115 (0.87%) 
Vomiting * 1  0/133 (0.00%)  0/116 (0.00%)  1/115 (0.87%) 
Infections and infestations       
Localised infection * 1  1/133 (0.75%)  1/116 (0.86%)  1/115 (0.87%) 
Osteomyelitis * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
Pneumonia * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin ulcer * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
Surgical and medical procedures       
Cholecystectomy * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
Coronary arterial stant insertion * 1  0/133 (0.00%)  1/116 (0.86%)  0/115 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sham Injection 0.5mg Ranibizumab 4-mg Triamcinolone Acetonided
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   57/133 (42.86%)   50/116 (43.10%)   66/115 (57.39%) 
Eye disorders       
Conjunctival haemorrhage * 1  2/133 (1.50%)  11/116 (9.48%)  8/115 (6.96%) 
Eye pain * 1  11/133 (8.27%)  7/116 (6.03%)  6/115 (5.22%) 
Intraocular pressure increase * 1  1/133 (0.75%)  0/116 (0.00%)  11/115 (9.57%) 
Myodesopsia * 1  5/133 (3.76%)  7/116 (6.03%)  10/115 (8.70%) 
Vision Blurred * 1  13/133 (9.77%)  8/116 (6.90%)  9/115 (7.83%) 
Vitreous floaters * 1  3/133 (2.26%)  4/116 (3.45%)  10/115 (8.70%) 
Vitreous haemorrhage * 1  15/133 (11.28%)  6/116 (5.17%)  7/115 (6.09%) 
General disorders       
headache * 1  7/133 (5.26%)  7/116 (6.03%)  5/115 (4.35%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Adam R. Glassman, Director DRCR.net Coordinating Center
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
EMail: aglassman@jaeb.org
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00445003     History of Changes
Other Study ID Numbers: NEI-134
U10EY018817-03 ( U.S. NIH Grant/Contract )
U10EY014229-07 ( U.S. NIH Grant/Contract )
U10EY014231-09 ( U.S. NIH Grant/Contract )
First Submitted: March 6, 2007
First Posted: March 8, 2007
Results First Submitted: April 14, 2011
Results First Posted: July 13, 2011
Last Update Posted: August 26, 2016