Trial Outcomes & Findings for A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema (NCT NCT00369486)
NCT ID: NCT00369486
Last Updated: 2016-08-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
4, 8, 17, 34 weeks
Results posted on
2016-08-26
Participant Flow
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.
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.
Participant milestones
| Measure |
Focal Laser Photocoagulation
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
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
4-Week Visit
STARTED
|
38
|
21
|
23
|
22
|
25
|
|
4-Week Visit
COMPLETED
|
36
|
19
|
22
|
20
|
24
|
|
4-Week Visit
NOT COMPLETED
|
2
|
2
|
1
|
2
|
1
|
|
8-Week Visit
STARTED
|
38
|
21
|
22
|
22
|
25
|
|
8-Week Visit
COMPLETED
|
38
|
20
|
22
|
21
|
24
|
|
8-Week Visit
NOT COMPLETED
|
0
|
1
|
0
|
1
|
1
|
|
17-Week Visit
STARTED
|
38
|
21
|
23
|
22
|
25
|
|
17-Week Visit
COMPLETED
|
38
|
21
|
22
|
21
|
24
|
|
17-Week Visit
NOT COMPLETED
|
0
|
0
|
1
|
1
|
1
|
|
34-Week Visit
STARTED
|
38
|
21
|
23
|
22
|
25
|
|
34-Week Visit
COMPLETED
|
38
|
20
|
22
|
19
|
22
|
|
34-Week Visit
NOT COMPLETED
|
0
|
1
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
Focal Laser Photocoagulation
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
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
4-Week Visit
Missed visit
|
2
|
2
|
0
|
2
|
1
|
|
4-Week Visit
Dropped
|
0
|
0
|
1
|
0
|
0
|
|
8-Week Visit
Missed visit
|
0
|
1
|
0
|
0
|
1
|
|
8-Week Visit
Dropped
|
0
|
0
|
0
|
1
|
0
|
|
17-Week Visit
Missed visit
|
0
|
0
|
1
|
1
|
1
|
|
34-Week Visit
Dropped
|
0
|
1
|
1
|
3
|
3
|
Baseline Characteristics
A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Focal Laser Photocoagulation
n=38 Participants
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
n=21 Participants
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
n=23 Participants
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
n=22 Participants
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
n=25 Participants
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 11 • n=99 Participants
|
58 years
STANDARD_DEVIATION 12 • n=107 Participants
|
60 years
STANDARD_DEVIATION 8 • n=206 Participants
|
64 years
STANDARD_DEVIATION 7 • n=7 Participants
|
63 years
STANDARD_DEVIATION 13 • n=31 Participants
|
60 years
STANDARD_DEVIATION 11 • n=30 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
47 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
82 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
31 participants
n=99 Participants
|
16 participants
n=107 Participants
|
21 participants
n=206 Participants
|
19 participants
n=7 Participants
|
19 participants
n=31 Participants
|
106 participants
n=30 Participants
|
|
Race/Ethnicity, Customized
African-American
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
4 participants
n=31 Participants
|
13 participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
5 participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
4 participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
1 participants
n=30 Participants
|
|
Cystoid Abnormality on Ocular Coherence Tomography (OCT)
Yes
|
30 eyes
n=99 Participants
|
17 eyes
n=107 Participants
|
20 eyes
n=206 Participants
|
18 eyes
n=7 Participants
|
19 eyes
n=31 Participants
|
104 eyes
n=30 Participants
|
|
Cystoid Abnormality on Ocular Coherence Tomography (OCT)
No
|
8 eyes
n=99 Participants
|
4 eyes
n=107 Participants
|
3 eyes
n=206 Participants
|
4 eyes
n=7 Participants
|
6 eyes
n=31 Participants
|
25 eyes
n=30 Participants
|
|
Diabetes Type
Type 1
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
|
Diabetes Type
Type 2
|
35 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
119 Participants
n=30 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity
>=79: 20/25 or better
|
25 eyes
n=99 Participants
|
12 eyes
n=107 Participants
|
17 eyes
n=206 Participants
|
10 eyes
n=7 Participants
|
11 eyes
n=31 Participants
|
75 eyes
n=30 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity
78-69: 20/32-20/40
|
13 eyes
n=99 Participants
|
9 eyes
n=107 Participants
|
6 eyes
n=206 Participants
|
12 eyes
n=7 Participants
|
14 eyes
n=31 Participants
|
54 eyes
n=30 Participants
|
|
Received Prior Focal Photocoagulation
No
|
21 eyes
n=99 Participants
|
7 eyes
n=107 Participants
|
8 eyes
n=206 Participants
|
10 eyes
n=7 Participants
|
11 eyes
n=31 Participants
|
57 eyes
n=30 Participants
|
|
Received Prior Focal Photocoagulation
Yes
|
17 eyes
n=99 Participants
|
14 eyes
n=107 Participants
|
15 eyes
n=206 Participants
|
12 eyes
n=7 Participants
|
14 eyes
n=31 Participants
|
72 eyes
n=30 Participants
|
|
Received Prior Scatter (Panretinal) Photocoagulation
No
|
34 eyes
n=99 Participants
|
16 eyes
n=107 Participants
|
19 eyes
n=206 Participants
|
21 eyes
n=7 Participants
|
25 eyes
n=31 Participants
|
115 eyes
n=30 Participants
|
|
Received Prior Scatter (Panretinal) Photocoagulation
Yes
|
4 eyes
n=99 Participants
|
5 eyes
n=107 Participants
|
4 eyes
n=206 Participants
|
1 eyes
n=7 Participants
|
0 eyes
n=31 Participants
|
14 eyes
n=30 Participants
|
|
Subretinal Fluid on Ocular Coherence Tomography (OCT)
Yes
|
4 eyes
n=99 Participants
|
1 eyes
n=107 Participants
|
0 eyes
n=206 Participants
|
1 eyes
n=7 Participants
|
2 eyes
n=31 Participants
|
8 eyes
n=30 Participants
|
|
Subretinal Fluid on Ocular Coherence Tomography (OCT)
No
|
34 eyes
n=99 Participants
|
20 eyes
n=107 Participants
|
23 eyes
n=206 Participants
|
21 eyes
n=7 Participants
|
23 eyes
n=31 Participants
|
121 eyes
n=30 Participants
|
|
Central Subfield Thickness
|
324 microns
STANDARD_DEVIATION 70 • n=99 Participants
|
321 microns
STANDARD_DEVIATION 53 • n=107 Participants
|
342 microns
STANDARD_DEVIATION 79 • n=206 Participants
|
319 microns
STANDARD_DEVIATION 59 • n=7 Participants
|
336 microns
STANDARD_DEVIATION 58 • n=31 Participants
|
328 microns
STANDARD_DEVIATION 65 • n=30 Participants
|
|
Duration of Diabetes
|
14 years
STANDARD_DEVIATION 10 • n=99 Participants
|
14 years
STANDARD_DEVIATION 9 • n=107 Participants
|
15 years
STANDARD_DEVIATION 7 • n=206 Participants
|
16 years
STANDARD_DEVIATION 7 • n=7 Participants
|
15 years
STANDARD_DEVIATION 9 • n=31 Participants
|
15 years
STANDARD_DEVIATION 9 • n=30 Participants
|
|
Hemoglobin A1c
|
7.9 percentage
STANDARD_DEVIATION 1.7 • n=99 Participants
|
7.3 percentage
STANDARD_DEVIATION 1.6 • n=107 Participants
|
8.1 percentage
STANDARD_DEVIATION 1.7 • n=206 Participants
|
7.8 percentage
STANDARD_DEVIATION 1.3 • n=7 Participants
|
7.5 percentage
STANDARD_DEVIATION 1.8 • n=31 Participants
|
7.8 percentage
STANDARD_DEVIATION 1.6 • n=30 Participants
|
|
Intraocular Pressure (mm Hg)
|
16 mm Hg
STANDARD_DEVIATION 3 • n=99 Participants
|
16 mm Hg
STANDARD_DEVIATION 4 • n=107 Participants
|
16 mm Hg
STANDARD_DEVIATION 4 • n=206 Participants
|
16 mm Hg
STANDARD_DEVIATION 3 • n=7 Participants
|
17 mm Hg
STANDARD_DEVIATION 3 • n=31 Participants
|
16 mm Hg
STANDARD_DEVIATION 3 • n=30 Participants
|
|
Mean visual acuity letter score
|
80 letter score
STANDARD_DEVIATION 5 • n=99 Participants
|
79 letter score
STANDARD_DEVIATION 4 • n=107 Participants
|
81 letter score
STANDARD_DEVIATION 5 • n=206 Participants
|
79 letter score
STANDARD_DEVIATION 7 • n=7 Participants
|
78 letter score
STANDARD_DEVIATION 6 • n=31 Participants
|
79 letter score
STANDARD_DEVIATION 5 • n=30 Participants
|
|
Total Retinal Volume (mm^3)
|
8.2 mm^3
STANDARD_DEVIATION 1.2 • n=99 Participants
|
7.6 mm^3
STANDARD_DEVIATION 0.9 • n=107 Participants
|
8.1 mm^3
STANDARD_DEVIATION 1.2 • n=206 Participants
|
7.8 mm^3
STANDARD_DEVIATION 0.6 • n=7 Participants
|
7.9 mm^3
STANDARD_DEVIATION 0.8 • n=31 Participants
|
8.0 mm^3
STANDARD_DEVIATION 1.0 • n=30 Participants
|
PRIMARY outcome
Timeframe: 4, 8, 17, 34 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Focal Laser Photocoagulation
n=38 Eyes
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
n=21 Eyes
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
n=23 Eyes
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
n=22 Eyes
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
n=25 Eyes
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
Change in Central Subfield Thickening From Baseline Through 34 Weeks
4 Weeks
|
-10 microns
Standard Deviation 53
|
-47 microns
Standard Deviation 51
|
-27 microns
Standard Deviation 36
|
-16 microns
Standard Deviation 60
|
-37 microns
Standard Deviation 66
|
|
Change in Central Subfield Thickening From Baseline Through 34 Weeks
8 Weeks
|
-27 microns
Standard Deviation 49
|
-29 microns
Standard Deviation 62
|
-38 microns
Standard Deviation 44
|
-25 microns
Standard Deviation 55
|
-44 microns
Standard Deviation 64
|
|
Change in Central Subfield Thickening From Baseline Through 34 Weeks
17 Weeks
|
-30 microns
Standard Deviation 60
|
-24 microns
Standard Deviation 91
|
-50 microns
Standard Deviation 49
|
-52 microns
Standard Deviation 45
|
-49 microns
Standard Deviation 79
|
|
Change in Central Subfield Thickening From Baseline Through 34 Weeks
34 Weeks
|
-54 microns
Standard Deviation 62
|
-31 microns
Standard Deviation 113
|
-45 microns
Standard Deviation 56
|
-45 microns
Standard Deviation 70
|
-68 microns
Standard Deviation 60
|
PRIMARY outcome
Timeframe: 4, 8, 17, and 34 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Focal Laser Photocoagulation
n=38 Eyes
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
n=21 Eyes
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
n=23 Eyes
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
n=22 Eyes
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
n=25 Eyes
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
Change in Visual Acuity Letter Score From Baseline Through 34 Weeks
4 Weeks
|
-1 letter score
Standard Deviation 5
|
1 letter score
Standard Deviation 4
|
-1 letter score
Standard Deviation 4
|
-2 letter score
Standard Deviation 6
|
-1 letter score
Standard Deviation 5
|
|
Change in Visual Acuity Letter Score From Baseline Through 34 Weeks
8 Weeks
|
-1 letter score
Standard Deviation 5
|
0 letter score
Standard Deviation 7
|
-1 letter score
Standard Deviation 6
|
0 letter score
Standard Deviation 4
|
0 letter score
Standard Deviation 6
|
|
Change in Visual Acuity Letter Score From Baseline Through 34 Weeks
17 Weeks
|
-2 letter score
Standard Deviation 5
|
-1 letter score
Standard Deviation 6
|
-2 letter score
Standard Deviation 5
|
-1 letter score
Standard Deviation 7
|
-1 letter score
Standard Deviation 7
|
|
Change in Visual Acuity Letter Score From Baseline Through 34 Weeks
34 Weeks
|
-2 letter score
Standard Deviation 12
|
-4 letter score
Standard Deviation 11
|
-1 letter score
Standard Deviation 5
|
-3 letter score
Standard Deviation 15
|
-1 letter score
Standard Deviation 7
|
PRIMARY outcome
Timeframe: 4, 8, 17, and 34 weeksPopulation: 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.
Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0
Outcome measures
| Measure |
Focal Laser Photocoagulation
n=38 Eyes
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
n=21 Eyes
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
n=23 Eyes
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
n=22 Eyes
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
n=25 Eyes
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
Mean Visual Acuity Letter Score at Each Follow-up Visit
4 Weeks
|
79 letter score
Standard Deviation 5
|
79 letter score
Standard Deviation 5
|
80 letter score
Standard Deviation 6
|
77 letter score
Standard Deviation 7
|
77 letter score
Standard Deviation 6
|
|
Mean Visual Acuity Letter Score at Each Follow-up Visit
8 Weeks
|
79 letter score
Standard Deviation 5
|
79 letter score
Standard Deviation 6
|
80 letter score
Standard Deviation 7
|
80 letter score
Standard Deviation 7
|
77 letter score
Standard Deviation 6
|
|
Mean Visual Acuity Letter Score at Each Follow-up Visit
17 Weeks
|
78 letter score
Standard Deviation 6
|
78 letter score
Standard Deviation 5
|
79 letter score
Standard Deviation 7
|
79 letter score
Standard Deviation 7
|
77 letter score
Standard Deviation 7
|
|
Mean Visual Acuity Letter Score at Each Follow-up Visit
34 Weeks
|
78 letter score
Standard Deviation 12
|
76 letter score
Standard Deviation 12
|
80 letter score
Standard Deviation 8
|
77 letter score
Standard Deviation 16
|
77 letter score
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 17 weeksPopulation: 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
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.
Outcome measures
| Measure |
Focal Laser Photocoagulation
n=38 Eyes
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
n=21 Eyes
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
n=22 Eyes
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
n=21 Eyes
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
n=24 Eyes
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks
Eyes that were retreated
|
22 eyes
|
15 eyes
|
14 eyes
|
9 eyes
|
9 eyes
|
|
Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks
Eyes with ≥ 250 central subfield thickness
|
26 eyes
|
14 eyes
|
16 eyes
|
11 eyes
|
13 eyes
|
SECONDARY outcome
Timeframe: 4, 8, 17, 34 weeksPopulation: 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
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.
Outcome measures
| Measure |
Focal Laser Photocoagulation
n=38 Eyes
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
n=21 Eyes
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
n=23 Eyes
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
n=22 Eyes
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
n=25 Eyes
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks
4 Weeks
|
5 eyes
|
8 eyes
|
2 eyes
|
4 eyes
|
8 eyes
|
|
Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks
8 Weeks
|
8 eyes
|
7 eyes
|
6 eyes
|
4 eyes
|
10 eyes
|
|
Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks
17 Weeks
|
11 eyes
|
6 eyes
|
8 eyes
|
7 eyes
|
13 eyes
|
|
Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks
34 Weeks
|
22 eyes
|
9 eyes
|
5 eyes
|
9 eyes
|
13 eyes
|
SECONDARY outcome
Timeframe: 4, 8, 17, 34 weeksPopulation: 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
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.
Outcome measures
| Measure |
Focal Laser Photocoagulation
n=38 Participants
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
n=21 Participants
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
n=23 Participants
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
n=22 Participants
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
n=25 Participants
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks
4 Weeks
|
5 eyes
|
5 eyes
|
3 eyes
|
2 eyes
|
8 eyes
|
|
Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks
8 Weeks
|
9 eyes
|
4 eyes
|
3 eyes
|
6 eyes
|
9 eyes
|
|
Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks
17 Weeks
|
11 eyes
|
7 eyes
|
6 eyes
|
10 eyes
|
11 eyes
|
|
Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks
34 Weeks
|
19 eyes
|
8 eyes
|
2 eyes
|
10 eyes
|
13 eyes
|
Adverse Events
Focal Laser Photocoagulation
Serious events: 13 serious events
Other events: 54 other events
Deaths: 0 deaths
Posterior Peribulbar Injection of 40 mg Triamcinolone
Serious events: 11 serious events
Other events: 53 other events
Deaths: 0 deaths
Anterior Peribulbar Injection of 20 mg Triamcinolone
Serious events: 7 serious events
Other events: 60 other events
Deaths: 0 deaths
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Focal Laser Photocoagulation
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
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/38
|
4.8%
1/21
|
0.00%
0/23
|
13.6%
3/22
|
0.00%
0/25
|
|
Cardiac disorders
Transient ischaemic attack
|
0.00%
0/38
|
0.00%
0/21
|
0.00%
0/23
|
9.1%
2/22
|
0.00%
0/25
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/38
|
0.00%
0/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Infections and infestations
Postoperative or localised infection
|
5.3%
2/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Cardiac operation
|
0.00%
0/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.3%
2/38
|
4.8%
1/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Heart failure
|
2.6%
1/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/38
|
4.8%
1/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
General disorders
Multi-organ failure
|
2.6%
1/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
General disorders
Fluid retention
|
2.6%
1/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Skin ulcer or skin lesion
|
2.6%
1/38
|
0.00%
0/21
|
8.7%
2/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Endocrine disorders
Diabetic gastroparesis
|
0.00%
0/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
4.0%
1/25
|
|
General disorders
Dizziness
|
0.00%
0/38
|
0.00%
0/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Osteomyelities acute
|
2.6%
1/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
General disorders
Oxygen saturation decreased
|
2.6%
1/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
1/38
|
4.8%
1/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Artery occlusion
|
0.00%
0/38
|
9.5%
2/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Chest discomfort
|
2.6%
1/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/38
|
4.8%
1/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/38
|
9.5%
2/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Surgical and medical procedures
Amputation
|
0.00%
0/38
|
0.00%
0/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Pulmonary embolism
|
0.00%
0/38
|
4.8%
1/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Cerebrovascular accident
|
2.6%
1/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
4.0%
1/25
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/38
|
4.8%
1/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
Other adverse events
| Measure |
Focal Laser Photocoagulation
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
Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
|
Anterior Peribulbar Injection of 20 mg Triamcinolone
Anterior peribulbar injection of 20 mg triamcinolone
|
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser
Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
|
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser
Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
|
|---|---|---|---|---|---|
|
Eye disorders
Ptosis
|
0.00%
0/38
|
19.0%
4/21
|
13.0%
3/23
|
4.5%
1/22
|
4.0%
1/25
|
|
Eye disorders
Elevated intraocular pressure/glaucoma (increase by 10mm Hg or more at any visit)
|
5.3%
2/38
|
14.3%
3/21
|
43.5%
10/23
|
22.7%
5/22
|
52.0%
13/25
|
|
Endocrine disorders
HbA1c (increase by 0.5% or more from baseline)
|
28.9%
11/38
|
23.8%
5/21
|
34.8%
8/23
|
22.7%
5/22
|
24.0%
6/25
|
|
Eye disorders
Cataract
|
7.9%
3/38
|
9.5%
2/21
|
17.4%
4/23
|
4.5%
1/22
|
20.0%
5/25
|
|
Eye disorders
Cataract cortical
|
2.6%
1/38
|
4.8%
1/21
|
8.7%
2/23
|
9.1%
2/22
|
0.00%
0/25
|
|
Eye disorders
Cataract subcapsular
|
5.3%
2/38
|
4.8%
1/21
|
13.0%
3/23
|
9.1%
2/22
|
8.0%
2/25
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/38
|
23.8%
5/21
|
39.1%
9/23
|
0.00%
0/22
|
4.0%
1/25
|
|
Endocrine disorders
Diabetic retinopathy
|
7.9%
3/38
|
9.5%
2/21
|
0.00%
0/23
|
0.00%
0/22
|
4.0%
1/25
|
|
Eye disorders
Eye pain
|
0.00%
0/38
|
14.3%
3/21
|
4.3%
1/23
|
0.00%
0/22
|
4.0%
1/25
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/38
|
9.5%
2/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Eye disorders
Vision blurred
|
5.3%
2/38
|
14.3%
3/21
|
4.3%
1/23
|
4.5%
1/22
|
4.0%
1/25
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/38
|
4.8%
1/21
|
4.3%
1/23
|
9.1%
2/22
|
12.0%
3/25
|
|
Eye disorders
Visual disturbance
|
7.9%
3/38
|
23.8%
5/21
|
0.00%
0/23
|
18.2%
4/22
|
4.0%
1/25
|
|
Eye disorders
Vitreous floaters
|
5.3%
2/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
4.0%
1/25
|
|
Eye disorders
Vitreous haemorrhage
|
18.4%
7/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Eye disorders
Subconjunctival haemorrhage
|
0.00%
0/38
|
0.00%
0/21
|
13.0%
3/23
|
0.00%
0/22
|
4.0%
1/25
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
2/38
|
9.5%
2/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/38
|
0.00%
0/21
|
8.7%
2/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/38
|
0.00%
0/21
|
13.0%
3/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/38
|
9.5%
2/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/38
|
14.3%
3/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Hypercholesterolaemia
|
5.3%
2/38
|
4.8%
1/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Hyperlipidaemia
|
5.3%
2/38
|
4.8%
1/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Cardiac disorders
Hypertension
|
5.3%
2/38
|
4.8%
1/21
|
8.7%
2/23
|
0.00%
0/22
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Limb injury
|
0.00%
0/38
|
9.5%
2/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
5.3%
2/38
|
0.00%
0/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/38
|
9.5%
2/21
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.3%
2/38
|
4.8%
1/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.3%
2/38
|
4.8%
1/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.6%
1/38
|
0.00%
0/21
|
8.7%
2/23
|
0.00%
0/22
|
0.00%
0/25
|
|
Renal and urinary disorders
Urinary tract infection
|
5.3%
2/38
|
0.00%
0/21
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/25
|
Additional Information
Adam R. Glassman, M.S., Director
Jaeb Center for Health Research, Diabetic Retinopathy Clinical Research Network
Phone: (813) 975-8690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place