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A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema (Peribulbar)

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ClinicalTrials.gov Identifier: NCT00369486
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : June 14, 2011
Last Update Posted : August 26, 2016
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by:
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Interventions Procedure: Focal laser photocoagulation
Drug: 40mg triamcinolone
Drug: 20mg triamcinolone
Drug: 40mg triamcinolone + laser
Drug: 20mg triamcinolone + laser
Enrollment 113
Recruitment Details Thirty-two clinical sites across the United States recruited 129 eyes of 109 subjects between December 2004 and September 2005. 113 subjects were randomized, but 4 were not included in any of the analysis because they were ineligible.
Pre-assignment Details 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 Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Hide Arm/Group Description Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting). Posterior peribulbar injection of 40 mg triamcinolone (Kenalog) Anterior peribulbar injection of 20 mg triamcinolone Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
Period Title: 4-Week Visit
Started 38 [1] 21 [1] 23 [1] 22 [1] 25 [1]
Completed 36 [1] 19 [2] 22 [1] 20 [1] 24 [1]
Not Completed 2 2 1 2 1
Reason Not Completed
Missed visit             2             2             0             2             1
Dropped             0             0             1             0             0
[1]
Number of eyes
[2]
Number of eyes;
Period Title: 8-Week Visit
Started 38 [1] 21 [1] 22 [1] 22 [1] 25 [1]
Completed 38 [1] 20 [1] 22 [1] 21 [1] 24 [1]
Not Completed 0 1 0 1 1
Reason Not Completed
Missed visit             0             1             0             0             1
Dropped             0             0             0             1             0
[1]
Number of eyes
Period Title: 17-Week Visit
Started 38 [1] 21 [1] 23 [1] 22 [1] 25 [1]
Completed 38 [1] 21 [1] 22 [1] 21 [1] 24 [1]
Not Completed 0 0 1 1 1
Reason Not Completed
Missed visit             0             0             1             1             1
[1]
Number of eyes
Period Title: 34-Week Visit
Started 38 [1] 21 [1] 23 [1] 22 [1] 25 [2]
Completed 38 [1] 20 [1] 22 [1] 19 [1] 22 [1]
Not Completed 0 1 1 3 3
Reason Not Completed
Dropped             0             1             1             3             3
[1]
Number of eyes
[2]
Number of eyes that
Arm/Group Title Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser Total
Hide Arm/Group Description Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting). Posterior peribulbar injection of 40 mg triamcinolone (Kenalog) Anterior peribulbar injection of 20 mg triamcinolone Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month Total of all reporting groups
Overall Number of Baseline Participants 38 21 23 22 25 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
58  (11) 58  (12) 60  (8) 64  (7) 63  (13) 60  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
Female
17
  44.7%
13
  61.9%
5
  21.7%
4
  18.2%
8
  32.0%
47
  36.4%
Male
21
  55.3%
8
  38.1%
18
  78.3%
18
  81.8%
17
  68.0%
82
  63.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
White 31 16 21 19 19 106
African-American 3 3 0 3 4 13
Hispanic or Latino 1 1 2 0 1 5
Asian 3 1 0 0 0 4
Other 0 0 0 0 1 1
Cystoid Abnormality on Ocular Coherence Tomography (OCT)  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
Yes 30 17 20 18 19 104
No 8 4 3 4 6 25
Diabetes Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
Type 1 3 3 3 0 1 10
Type 2 35 18 20 22 24 119
Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
>=79: 20/25 or better 25 12 17 10 11 75
78-69: 20/32-20/40 13 9 6 12 14 54
[1]
Measure Description: Best corrected visual acuity letter score as measured by a certified tester using an electronic early treatment diabetic retinopathy study (e-ETDRS) method and approximate Snellen equivalent. Best value on the scale is 97, worst value 0.
Received Prior Focal Photocoagulation  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
No 21 7 8 10 11 57
Yes 17 14 15 12 14 72
Received Prior Scatter (Panretinal) Photocoagulation  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
No 34 16 19 21 25 115
Yes 4 5 4 1 0 14
Subretinal Fluid on Ocular Coherence Tomography (OCT)   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
Yes 4 1 0 1 2 8
No 34 20 23 21 23 121
[1]
Measure Description: Ocular Coherence Tomography (OCT) images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.
Central Subfield Thickness   [1] 
Mean (Standard Deviation)
Unit of measure:  Microns
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
324  (70) 321  (53) 342  (79) 319  (59) 336  (58) 328  (65)
[1]
Measure Description: Measured by Ocular Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.
Duration of Diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
14  (10) 14  (9) 15  (7) 16  (7) 15  (9) 15  (9)
[1]
Measure Description: N=129 eyes
Hemoglobin A1c  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
7.9  (1.7) 7.3  (1.6) 8.1  (1.7) 7.8  (1.3) 7.5  (1.8) 7.8  (1.6)
Intraocular Pressure (mm Hg)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
16  (3) 16  (4) 16  (4) 16  (3) 17  (3) 16  (3)
[1]
Measure Description: N=129 eyes
Mean visual acuity letter score   [1] 
Mean (Standard Deviation)
Unit of measure:  Letter score
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
80  (5) 79  (4) 81  (5) 79  (7) 78  (6) 79  (5)
[1]
Measure Description: Baseline Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) Visual Acuity Letter Score: best value = 97; letter score worst value = 0
Total Retinal Volume (mm^3)  
Mean (Standard Deviation)
Unit of measure:  Mm^3
Number Analyzed 38 participants 21 participants 23 participants 22 participants 25 participants 129 participants
8.2  (1.2) 7.6  (0.9) 8.1  (1.2) 7.8  (0.6) 7.9  (0.8) 8.0  (1.0)
1.Primary Outcome
Title Change in Central Subfield Thickening From Baseline Through 34 Weeks
Hide Description Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. Negative changes represent a decrease in retinal thickening.
Time Frame 4, 8, 17, 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward was used. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.
Arm/Group Title Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Hide Arm/Group Description:
Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
Anterior peribulbar injection of 20 mg triamcinolone
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
Overall Number of Participants Analyzed 38 21 23 22 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
38 21 23 22 25
Mean (Standard Deviation)
Unit of Measure: microns
4 Weeks -10  (53) -47  (51) -27  (36) -16  (60) -37  (66)
8 Weeks -27  (49) -29  (62) -38  (44) -25  (55) -44  (64)
17 Weeks -30  (60) -24  (91) -50  (49) -52  (45) -49  (79)
34 Weeks -54  (62) -31  (113) -45  (56) -45  (70) -68  (60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Posterior Peribulbar Injection of 40 mg Triamcinolone, Anterior Peribulbar Injection of 20 mg Triamcinolone, Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser, Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Comments Comparison of change in central subfield thickening from baseline to 34 weeks in all five groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments Adjusted for baseline central subfield thickness
Method repeated measures least sq. regression
Comments Models adjusted for baseline values and for correlated data from subjects with two study eyes.
2.Primary Outcome
Title Change in Visual Acuity Letter Score From Baseline Through 34 Weeks
Hide Description Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity.
Time Frame 4, 8, 17, and 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.
Arm/Group Title Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Hide Arm/Group Description:
Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
Anterior peribulbar injection of 20 mg triamcinolone
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
Overall Number of Participants Analyzed 38 21 23 22 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
38 21 23 22 25
Mean (Standard Deviation)
Unit of Measure: letter score
4 Weeks -1  (5) 1  (4) -1  (4) -2  (6) -1  (5)
8 Weeks -1  (5) 0  (7) -1  (6) 0  (4) 0  (6)
17 Weeks -2  (5) -1  (6) -2  (5) -1  (7) -1  (7)
34 Weeks -2  (12) -4  (11) -1  (5) -3  (15) -1  (7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Focal Laser Photocoagulation, Posterior Peribulbar Injection of 40 mg Triamcinolone, Anterior Peribulbar Injection of 20 mg Triamcinolone, Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser, Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Comments Comparison of the mean change in visual acuity letter score among the five groups at 34 weeks. Negative changes represent a worsening in visual acuity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method repeated measures least sq. regression
Comments Adjusted for baseline values and for the correlated data from subjects with two study eyes.
3.Primary Outcome
Title Mean Visual Acuity Letter Score at Each Follow-up Visit
Hide Description Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0
Time Frame 4, 8, 17, and 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.
Arm/Group Title Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Hide Arm/Group Description:
Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
Anterior peribulbar injection of 20 mg triamcinolone
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
Overall Number of Participants Analyzed 38 21 23 22 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
38 21 23 22 25
Mean (Standard Deviation)
Unit of Measure: letter score
4 Weeks 79  (5) 79  (5) 80  (6) 77  (7) 77  (6)
8 Weeks 79  (5) 79  (6) 80  (7) 80  (7) 77  (6)
17 Weeks 78  (6) 78  (5) 79  (7) 79  (7) 77  (7)
34 Weeks 78  (12) 76  (12) 80  (8) 77  (16) 77  (7)
4.Secondary Outcome
Title Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks
Hide Description Number of eyes that were retreated at 17 weeks. According to the protocol, primary criterion for retreatment was central subfield thickness >=250 microns or macular edema was still present according to the investigator's judgment.
Time Frame 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit
Arm/Group Title Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Hide Arm/Group Description:
Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
Anterior peribulbar injection of 20 mg triamcinolone
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
Overall Number of Participants Analyzed 38 21 22 21 24
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
38 21 22 21 24
Measure Type: Number
Unit of Measure: eyes
Eyes that were retreated 22 15 14 9 9
Eyes with ≥ 250 central subfield thickness 26 14 16 11 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Focal Laser Photocoagulation, Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser, Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Comments Analysis combined posterior and anterior injection + laser groups to compare with laser only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method generalized estimating equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.5
Confidence Interval 95%
0.2 to 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Focal Laser Photocoagulation, Posterior Peribulbar Injection of 40 mg Triamcinolone, Anterior Peribulbar Injection of 20 mg Triamcinolone
Comments Analysis combined posterior and anterior injection only groups to compare with laser only treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method generalized estimating equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.2
Confidence Interval 95%
0.5 to 2.9
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks
Hide Description Number of eyes that had a reduction in central subfield retinal thickness by ≥ 50% at each follow-up. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.
Time Frame 4, 8, 17, 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit
Arm/Group Title Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Hide Arm/Group Description:
Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
Anterior peribulbar injection of 20 mg triamcinolone
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
Overall Number of Participants Analyzed 38 21 23 22 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
38 21 23 22 25
Measure Type: Number
Unit of Measure: eyes
4 Weeks 5 8 2 4 8
8 Weeks 8 7 6 4 10
17 Weeks 11 6 8 7 13
34 Weeks 22 9 5 9 13
6.Secondary Outcome
Title Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks
Hide Description Primary criterion for retreatment is central subfield thickness >=250 microns. Central subfield thickness of <250 microns indicates no need for retreatment. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.
Time Frame 4, 8, 17, 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit
Arm/Group Title Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Hide Arm/Group Description:
Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
Anterior peribulbar injection of 20 mg triamcinolone
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
Overall Number of Participants Analyzed 38 21 23 22 25
Measure Type: Number
Unit of Measure: eyes
4 Weeks 5 5 3 2 8
8 Weeks 9 4 3 6 9
17 Weeks 11 7 6 10 11
34 Weeks 19 8 2 10 13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Hide Arm/Group Description Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting). Posterior peribulbar injection of 40 mg triamcinolone (Kenalog) Anterior peribulbar injection of 20 mg triamcinolone Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
All-Cause Mortality
Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13      11      7      5      3    
Blood and lymphatic system disorders           
Anaemia *  1/38 (2.63%)  1/21 (4.76%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Cardiac disorders           
Myocardial infarction *  0/38 (0.00%)  1/21 (4.76%)  0/23 (0.00%)  3/22 (13.64%)  0/25 (0.00%) 
Transient ischaemic attack *  0/38 (0.00%)  0/21 (0.00%)  0/23 (0.00%)  2/22 (9.09%)  0/25 (0.00%) 
Arteriosclerosis coronary artery *  0/38 (0.00%)  0/21 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Cardiac operation *  0/38 (0.00%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/25 (4.00%) 
Heart failure *  1/38 (2.63%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Artery occlusion *  0/38 (0.00%)  2/21 (9.52%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Chest discomfort *  1/38 (2.63%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Pulmonary embolism *  0/38 (0.00%)  1/21 (4.76%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Cerebrovascular accident *  1/38 (2.63%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/25 (4.00%) 
Endocrine disorders           
Diabetic gastroparesis *  0/38 (0.00%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders           
Gastric ulcer *  0/38 (0.00%)  1/21 (4.76%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
General disorders           
Multi-organ failure *  1/38 (2.63%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Fluid retention *  1/38 (2.63%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Dizziness *  0/38 (0.00%)  0/21 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Oxygen saturation decreased *  1/38 (2.63%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Infections and infestations           
Postoperative or localised infection *  2/38 (5.26%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Musculoskeletal and connective tissue disorders           
Osteomyelities acute *  1/38 (2.63%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Spinal column stenosis *  0/38 (0.00%)  1/21 (4.76%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Osteomyelitis *  0/38 (0.00%)  2/21 (9.52%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Renal and urinary disorders           
Renal failure *  0/38 (0.00%)  1/21 (4.76%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Pneumonia *  2/38 (5.26%)  1/21 (4.76%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders           
Skin ulcer or skin lesion *  1/38 (2.63%)  0/21 (0.00%)  2/23 (8.70%)  0/22 (0.00%)  0/25 (0.00%) 
Surgical and medical procedures           
Amputation *  0/38 (0.00%)  0/21 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Focal Laser Photocoagulation Posterior Peribulbar Injection of 40 mg Triamcinolone Anterior Peribulbar Injection of 20 mg Triamcinolone Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54      53      60      23      38    
Blood and lymphatic system disorders           
Anaemia *  2/38 (5.26%)  2/21 (9.52%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Cardiac disorders           
Arteriosclerosis coronary artery *  0/38 (0.00%)  0/21 (0.00%)  2/23 (8.70%)  0/22 (0.00%)  0/25 (0.00%) 
Hypercholesterolaemia *  2/38 (5.26%)  1/21 (4.76%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Hyperlipidaemia *  2/38 (5.26%)  1/21 (4.76%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Hypertension *  2/38 (5.26%)  1/21 (4.76%)  2/23 (8.70%)  0/22 (0.00%)  1/25 (4.00%) 
Endocrine disorders           
HbA1c (increase by 0.5% or more from baseline)   11/38 (28.95%)  5/21 (23.81%)  8/23 (34.78%)  5/22 (22.73%)  6/25 (24.00%) 
Diabetic retinopathy   3/38 (7.89%)  2/21 (9.52%)  0/23 (0.00%)  0/22 (0.00%)  1/25 (4.00%) 
Eye disorders           
Ptosis *  0/38 (0.00%)  0 4/21 (19.05%)  3/23 (13.04%)  1/22 (4.55%)  1/25 (4.00%) 
Elevated intraocular pressure/glaucoma (increase by 10mm Hg or more at any visit)   2/38 (5.26%)  3/21 (14.29%)  10/23 (43.48%)  5/22 (22.73%)  13/25 (52.00%) 
Cataract   3/38 (7.89%)  2/21 (9.52%)  4/23 (17.39%)  1/22 (4.55%)  5/25 (20.00%) 
Cataract cortical   1/38 (2.63%)  1/21 (4.76%)  2/23 (8.70%)  2/22 (9.09%)  0/25 (0.00%) 
Cataract subcapsular   2/38 (5.26%)  1/21 (4.76%)  3/23 (13.04%)  2/22 (9.09%)  2/25 (8.00%) 
Conjunctival haemorrhage   0/38 (0.00%)  5/21 (23.81%)  9/23 (39.13%)  0/22 (0.00%)  1/25 (4.00%) 
Eye pain   0/38 (0.00%)  3/21 (14.29%)  1/23 (4.35%)  0/22 (0.00%)  1/25 (4.00%) 
Lacrimation increased   0/38 (0.00%)  2/21 (9.52%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Vision blurred   2/38 (5.26%)  3/21 (14.29%)  1/23 (4.35%)  1/22 (4.55%)  1/25 (4.00%) 
Visual acuity reduced   0/38 (0.00%)  1/21 (4.76%)  1/23 (4.35%)  2/22 (9.09%)  3/25 (12.00%) 
Visual disturbance   3/38 (7.89%)  5/21 (23.81%)  0/23 (0.00%)  4/22 (18.18%)  1/25 (4.00%) 
Vitreous floaters   2/38 (5.26%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/25 (4.00%) 
Vitreous haemorrhage   7/38 (18.42%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Subconjunctival haemorrhage   0/38 (0.00%)  0/21 (0.00%)  3/23 (13.04%)  0/22 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders           
Diarrhoea *  0/38 (0.00%)  2/21 (9.52%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Gastric ulcer *  0/38 (0.00%)  3/21 (14.29%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Musculoskeletal and connective tissue disorders           
Limb injury *  0/38 (0.00%)  2/21 (9.52%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Osteomyelitis *  0/38 (0.00%)  2/21 (9.52%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Renal and urinary disorders           
Urinary tract infection *  2/38 (5.26%)  0/21 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough *  1/38 (2.63%)  0/21 (0.00%)  3/23 (13.04%)  0/22 (0.00%)  0/25 (0.00%) 
Nasopharyngitis *  2/38 (5.26%)  0/21 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/25 (0.00%) 
Pneumonia *  2/38 (5.26%)  1/21 (4.76%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Upper respiratory tract infection *  1/38 (2.63%)  0/21 (0.00%)  2/23 (8.70%)  0/22 (0.00%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders           
Skin ulcer *  2/38 (5.26%)  1/21 (4.76%)  1/23 (4.35%)  0/22 (0.00%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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, M.S., Director
Organization: Jaeb Center for Health Research, Diabetic Retinopathy Clinical Research Network
Phone: (813) 975-8690
Responsible Party: Roy W. Beck, M.D., Ph.D., Director, Jaeb Center for Health Research (DRCR.net)
ClinicalTrials.gov Identifier: NCT00369486     History of Changes
Other Study ID Numbers: NEI-104
U10EY018817-03 ( U.S. NIH Grant/Contract )
U10EY014229-07 ( U.S. NIH Grant/Contract )
U10EY014231-09 ( U.S. NIH Grant/Contract )
First Submitted: August 25, 2006
First Posted: August 29, 2006
Results First Submitted: October 14, 2009
Results First Posted: June 14, 2011
Last Update Posted: August 26, 2016