Trial Outcomes & Findings for Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema (NCT NCT00367133)
NCT ID: NCT00367133
Last Updated: 2016-08-26
Results Overview
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
840 participants
Primary outcome timeframe
Baseline to 2 Years
Results posted on
2016-08-26
Participant Flow
Eighty-eight academic and community based sites across the United States recruited 693 subjects from May 2004 to July 2006.
Participant milestones
| Measure |
Focal/Grid Laser Photocoagulation
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
2 Years
STARTED
|
330
|
256
|
254
|
|
2 Years
COMPLETED
|
272
|
220
|
205
|
|
2 Years
NOT COMPLETED
|
58
|
36
|
49
|
|
3 Years
STARTED
|
143
|
116
|
116
|
|
3 Years
COMPLETED
|
115
|
93
|
98
|
|
3 Years
NOT COMPLETED
|
28
|
23
|
18
|
Reasons for withdrawal
| Measure |
Focal/Grid Laser Photocoagulation
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
2 Years
Death
|
20
|
12
|
12
|
|
2 Years
Dropped
|
34
|
19
|
33
|
|
2 Years
Missed visit
|
4
|
5
|
4
|
Baseline Characteristics
Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Focal/Grid Laser Photocoagulation
n=330 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=256 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=254 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
Total
n=840 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
63 years
n=107 Participants
|
63 years
n=206 Participants
|
63 years
n=157 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
411 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=99 Participants
|
136 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
429 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
White
|
243 participants
n=99 Participants
|
186 participants
n=107 Participants
|
183 participants
n=206 Participants
|
612 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Black
|
31 participants
n=99 Participants
|
22 participants
n=107 Participants
|
26 participants
n=206 Participants
|
79 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
39 participants
n=99 Participants
|
34 participants
n=107 Participants
|
33 participants
n=206 Participants
|
106 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
5 participants
n=206 Participants
|
20 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
6 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/other Pacific Islander
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Unknown/not reported
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
13 participants
n=157 Participants
|
|
Diabetes Type
Type 1
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
38 Participants
n=157 Participants
|
|
Diabetes Type
Type 2
|
316 Participants
n=99 Participants
|
244 Participants
n=107 Participants
|
242 Participants
n=206 Participants
|
802 Participants
n=157 Participants
|
|
History of ocular hypertension
Ocular Hypertension
|
3 Eyes
n=99 Participants
|
8 Eyes
n=107 Participants
|
4 Eyes
n=206 Participants
|
15 Eyes
n=157 Participants
|
|
History of ocular hypertension
No Ocular Hypertension
|
327 Eyes
n=99 Participants
|
248 Eyes
n=107 Participants
|
250 Eyes
n=206 Participants
|
825 Eyes
n=157 Participants
|
|
Lens status phakic (clinical examination)
Phakic
|
262 Eyes
n=99 Participants
|
203 Eyes
n=107 Participants
|
197 Eyes
n=206 Participants
|
662 Eyes
n=157 Participants
|
|
Lens status phakic (clinical examination)
Pseudophakic
|
68 Eyes
n=99 Participants
|
53 Eyes
n=107 Participants
|
57 Eyes
n=206 Participants
|
178 Eyes
n=157 Participants
|
|
OCT cystoid abnormality (questionable or definite)
OCT cystoid abnormality (questionable or definite)
|
315 Eyes
n=99 Participants
|
243 Eyes
n=107 Participants
|
246 Eyes
n=206 Participants
|
804 Eyes
n=157 Participants
|
|
OCT cystoid abnormality (questionable or definite)
No Evidence
|
12 Eyes
n=99 Participants
|
9 Eyes
n=107 Participants
|
6 Eyes
n=206 Participants
|
27 Eyes
n=157 Participants
|
|
OCT cystoid abnormality (questionable or definite)
Missing/can not grade
|
3 Eyes
n=99 Participants
|
4 Eyes
n=107 Participants
|
2 Eyes
n=206 Participants
|
9 Eyes
n=157 Participants
|
|
OCT subretinal fluid present (questionable or definite
OCT subretinal fluid present
|
94 Eyes
n=99 Participants
|
64 Eyes
n=107 Participants
|
61 Eyes
n=206 Participants
|
219 Eyes
n=157 Participants
|
|
OCT subretinal fluid present (questionable or definite
Missing (or ungradeable)
|
1 Eyes
n=99 Participants
|
4 Eyes
n=107 Participants
|
1 Eyes
n=206 Participants
|
6 Eyes
n=157 Participants
|
|
OCT subretinal fluid present (questionable or definite
No OCT subretinal fluid present
|
235 Eyes
n=99 Participants
|
188 Eyes
n=107 Participants
|
192 Eyes
n=206 Participants
|
615 Eyes
n=157 Participants
|
|
Prior Panretinal scatter photocoagulation
Prior Panretinal scatter photocoagulation
|
53 Eyes
n=99 Participants
|
40 Eyes
n=107 Participants
|
42 Eyes
n=206 Participants
|
135 Eyes
n=157 Participants
|
|
Prior Panretinal scatter photocoagulation
No Prior Panretinal scatter photocoagulation
|
277 Eyes
n=99 Participants
|
216 Eyes
n=107 Participants
|
212 Eyes
n=206 Participants
|
705 Eyes
n=157 Participants
|
|
Prior photocoagulation for diabetic macular edema
Prior photocoagulation for DME
|
198 Eyes
n=99 Participants
|
154 Eyes
n=107 Participants
|
158 Eyes
n=206 Participants
|
510 Eyes
n=157 Participants
|
|
Prior photocoagulation for diabetic macular edema
No Prior photocoagulation for DME
|
132 Eyes
n=99 Participants
|
102 Eyes
n=107 Participants
|
96 Eyes
n=206 Participants
|
330 Eyes
n=157 Participants
|
|
Retinopathy severity (ETDRS severity scale)
Microaneurysms only
|
1 Eyes
n=99 Participants
|
1 Eyes
n=107 Participants
|
0 Eyes
n=206 Participants
|
2 Eyes
n=157 Participants
|
|
Retinopathy severity (ETDRS severity scale)
Mild-moderately severe nonproliferative
|
186 Eyes
n=99 Participants
|
156 Eyes
n=107 Participants
|
151 Eyes
n=206 Participants
|
493 Eyes
n=157 Participants
|
|
Retinopathy severity (ETDRS severity scale)
Severe nonproliferative
|
43 Eyes
n=99 Participants
|
27 Eyes
n=107 Participants
|
25 Eyes
n=206 Participants
|
95 Eyes
n=157 Participants
|
|
Retinopathy severity (ETDRS severity scale)
Mild to moderate proliferative
|
79 Eyes
n=99 Participants
|
56 Eyes
n=107 Participants
|
62 Eyes
n=206 Participants
|
197 Eyes
n=157 Participants
|
|
Retinopathy severity (ETDRS severity scale)
High-risk proliferative
|
9 Eyes
n=99 Participants
|
8 Eyes
n=107 Participants
|
6 Eyes
n=206 Participants
|
23 Eyes
n=157 Participants
|
|
Retinopathy severity (ETDRS severity scale)
Missing (ungradeable)
|
12 Eyes
n=99 Participants
|
8 Eyes
n=107 Participants
|
10 Eyes
n=206 Participants
|
30 Eyes
n=157 Participants
|
|
Visual Acuity Categorized by Randomization Strata
73-60 (20/32-2-20/62)
|
189 Eyes
n=99 Participants
|
149 Eyes
n=107 Participants
|
149 Eyes
n=206 Participants
|
487 Eyes
n=157 Participants
|
|
Visual Acuity Categorized by Randomization Strata
59-36 (<20/631-20/200)
|
129 Eyes
n=99 Participants
|
94 Eyes
n=107 Participants
|
92 Eyes
n=206 Participants
|
315 Eyes
n=157 Participants
|
|
Visual Acuity Categorized by Randomization Strata
35-24 (20/200-20/320)
|
12 Eyes
n=99 Participants
|
13 Eyes
n=107 Participants
|
13 Eyes
n=206 Participants
|
38 Eyes
n=157 Participants
|
|
Central subfield thickness on OCT
|
398 Microns
n=99 Participants
|
405 Microns
n=107 Participants
|
396 Microns
n=206 Participants
|
400 Microns
n=157 Participants
|
|
Duration of Diabetes
|
15 Years
n=99 Participants
|
15 Years
n=107 Participants
|
16 Years
n=206 Participants
|
15 Years
n=157 Participants
|
|
HbA1c
|
7.5 Percentage
n=99 Participants
|
7.5 Percentage
n=107 Participants
|
7.6 Percentage
n=206 Participants
|
7.5 Percentage
n=157 Participants
|
|
Intraocular pressure
|
16 microns
n=99 Participants
|
16 microns
n=107 Participants
|
16 microns
n=206 Participants
|
16 microns
n=157 Participants
|
|
Retinal volume on OCT
|
9.2 cubic millimetre
n=99 Participants
|
8.9 cubic millimetre
n=107 Participants
|
8.9 cubic millimetre
n=206 Participants
|
9.0 cubic millimetre
n=157 Participants
|
|
e-ETDRS visual acuity
|
62 Letter Score
n=99 Participants
|
62 Letter Score
n=107 Participants
|
62 Letter Score
n=206 Participants
|
62 Letter Score
n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 YearsPopulation: The primary analysis included all randomized eyes and followed the intent-to-treat principle.
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=330 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=256 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=254 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
|
1 Letter score
Standard Deviation 17
|
-2 Letter score
Standard Deviation 18
|
-3 Letter score
Standard Deviation 22
|
PRIMARY outcome
Timeframe: Baseline to 2 YearsPopulation: The primary analysis included all randomized eyes and followed the intent-to-treat principle.
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=330 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=256 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=254 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Median Change in Visual Acuity Baseline to 2 Years
|
4 Letter score
Interval -6.0 to 11.0
|
1 Letter score
Interval -11.0 to 9.0
|
2 Letter score
Interval -11.0 to 11.0
|
PRIMARY outcome
Timeframe: baseline to 2 yearsPopulation: The primary analysis included all randomized eyes and followed the intent-to-treat principle
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=330 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=256 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=254 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Distribution of Change in Visual Acuity Baseline to 2 Years
>= 15 letter improvement
|
18 Percentage of Eyes
|
14 Percentage of Eyes
|
17 Percentage of Eyes
|
|
Distribution of Change in Visual Acuity Baseline to 2 Years
14 to 10 letter improvement
|
13 Percentage of Eyes
|
11 Percentage of Eyes
|
11 Percentage of Eyes
|
|
Distribution of Change in Visual Acuity Baseline to 2 Years
9 to 5 letter improvement
|
16 Percentage of Eyes
|
14 Percentage of Eyes
|
15 Percentage of Eyes
|
|
Distribution of Change in Visual Acuity Baseline to 2 Years
same +- 4 letters
|
24 Percentage of Eyes
|
27 Percentage of Eyes
|
23 Percentage of Eyes
|
|
Distribution of Change in Visual Acuity Baseline to 2 Years
5-9 letters worse
|
10 Percentage of Eyes
|
9 Percentage of Eyes
|
6 Percentage of Eyes
|
|
Distribution of Change in Visual Acuity Baseline to 2 Years
10-14 letters worse
|
5 Percentage of Eyes
|
6 Percentage of Eyes
|
8 Percentage of Eyes
|
|
Distribution of Change in Visual Acuity Baseline to 2 Years
>=15 letters worse
|
14 Percentage of Eyes
|
20 Percentage of Eyes
|
20 Percentage of Eyes
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Only subjects with an available Optical coherence tomography (OCT) at baseline and 2 years are included in the OCT analysis.
Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=261 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=207 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=193 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Central Subfield Thickness at 2 Years
|
243 Microns
Inter-Quartile Range 148 • Interval 197.0 to 326.0
|
305 Microns
Inter-Quartile Range 167 • Interval 231.0 to 406.0
|
279 Microns
Inter-Quartile Range 160 • Interval 228.0 to 430.0
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=261 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=207 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=193 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Mean Change in Central Subfield Thickness Baseline to 2 Years
|
-139 Microns
Standard Deviation 148
|
-86 Microns
Standard Deviation 167
|
-77 Microns
Standard Deviation 160
|
SECONDARY outcome
Timeframe: Baseline to 2 YearsPopulation: Only subjects with an available OCT's at baseline and 2 years are included in the OCT analysis.
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=261 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=207 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=193 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Median Change in Central Subfield Thickness Baseline to 2 Years
|
-131 Microns
Interval -217.0 to -49.0
|
-74 Microns
Interval -168.0 to -3.0
|
-76 Microns
Interval -175.0 to 11.0
|
SECONDARY outcome
Timeframe: Baseline to 2 YearsPopulation: Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=261 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=207 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=193 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years
|
67 Percentage of Eyes
|
46 Percentage of Eyes
|
48 Percentage of Eyes
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=261 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=207 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=193 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Central Subfield Thickness < 250 Microns at 2 Years
|
53 Percentage of Eyes
|
34 Percentage of Eyes
|
38 Percentage of Eyes
|
SECONDARY outcome
Timeframe: Baseline to 3 yearPopulation: The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=115 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=93 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=98 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Change in Visual Acuity From Baseline to 3 Years
|
5 Letter Score
Standard Deviation 17
|
0 Letter Score
Standard Deviation 16
|
0 Letter Score
Standard Deviation 21
|
SECONDARY outcome
Timeframe: Baseline to 3 yearPopulation: The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=115 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=93 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=98 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Change in Visual Acuity From Baseline to 3 Years
|
8 Letter Score
Interval -2.0 to 15.0
|
2 Letter Score
Interval -11.0 to 9.0
|
4 Letter Score
Interval -8.0 to 14.0
|
SECONDARY outcome
Timeframe: Baseline to 3 yearsPopulation: The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=115 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=93 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=98 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Distribution of Visual Acuity Change Baseline to 3 Years
10-14 letters worse
|
4 Percentage of Eyes
|
9 Percentage of Eyes
|
6 Percentage of Eyes
|
|
Distribution of Visual Acuity Change Baseline to 3 Years
>= 15 letters better
|
26 Percentage of Eyes
|
20 Percentage of Eyes
|
21 Percentage of Eyes
|
|
Distribution of Visual Acuity Change Baseline to 3 Years
10-14 letters better
|
18 Percentage of Eyes
|
4 Percentage of Eyes
|
16 Percentage of Eyes
|
|
Distribution of Visual Acuity Change Baseline to 3 Years
5-9 letters better
|
18 Percentage of Eyes
|
17 Percentage of Eyes
|
9 Percentage of Eyes
|
|
Distribution of Visual Acuity Change Baseline to 3 Years
no change, + - 4 letters
|
21 Percentage of Eyes
|
23 Percentage of Eyes
|
24 Percentage of Eyes
|
|
Distribution of Visual Acuity Change Baseline to 3 Years
5-9 letters worse
|
4 Percentage of Eyes
|
10 Percentage of Eyes
|
6 Percentage of Eyes
|
|
Distribution of Visual Acuity Change Baseline to 3 Years
>=15 letters worse
|
8 Percentage of Eyes
|
17 Percentage of Eyes
|
16 Percentage of Eyes
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=111 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=87 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=89 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years
|
211 Microns
Interval 175.0 to 271.0
|
269 Microns
Interval 210.0 to 299.0
|
248 Microns
Interval 195.0 to 342.0
|
SECONDARY outcome
Timeframe: Baseline to 3 yearsPopulation: The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=111 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=87 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=89 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Change in Central Subfield Thickness on OCT Baseline to 3 Years
|
-175 Microns
Standard Deviation 149
|
-124 Microns
Standard Deviation 184
|
-126 Microns
Standard Deviation 159
|
SECONDARY outcome
Timeframe: baseline to 3 yearsPopulation: The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=111 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=87 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=89 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Change in Central Subfield Thickness on OCT Baseline to 3 Years
|
-158 Microns
Interval -273.0 to -75.0
|
-103 Microns
Interval -248.0 to 4.0
|
-114 Microns
Interval -224.0 to -50.0
|
SECONDARY outcome
Timeframe: Baseline to 3 yearsPopulation: The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.
Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.
Outcome measures
| Measure |
Focal/Grid Laser Photocoagulation
n=111 Participants
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=87 Participants
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=89 Participants
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years
|
68 Percentage of Eyes
|
43 Percentage of Eyes
|
51 Percentage of Eyes
|
Adverse Events
Focal/Grid Laser Photocoagulation
Serious events: 135 serious events
Other events: 69 other events
Deaths: 0 deaths
1mg Intravitreal Triamcinolone
Serious events: 69 serious events
Other events: 98 other events
Deaths: 0 deaths
4 mg Intravitreal Triamcinolone
Serious events: 54 serious events
Other events: 163 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Focal/Grid Laser Photocoagulation
n=330 participants at risk
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=256 participants at risk
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=254 participants at risk
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
General disorders
Abdominal discomfort
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
General disorders
Abdominal hernia
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Abdominal pain
|
1.2%
4/330
|
0.39%
1/256
|
0.79%
2/254
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Skin and subcutaneous tissue disorders
Allergy to arthropod bite
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Blood and lymphatic system disorders
Anaemia
|
0.91%
3/330
|
0.00%
0/256
|
0.79%
2/254
|
|
Cardiac disorders
Angina unstable
|
0.61%
2/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Vascular disorders
Angioplasty
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Vascular disorders
Arterial occlusive disease
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Vascular disorders
Arteriosclerosis coronary artery
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Respiratory, thoracic and mediastinal disorders
Asbestosis
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Cardiac disorders
Atrial flutter
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Cardiac disorders
Atrioventricular block
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Bladder transitional cell carcinoma
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Eye disorders
Blindness
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Blood and lymphatic system disorders
Blood count abnormal
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Blood and lymphatic system disorders
Blood electrolytes decreased
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Blood and lymphatic system disorders
Blood glucose abnormal
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Blood and lymphatic system disorders
Blood glucose decreased
|
0.61%
2/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Blood and lymphatic system disorders
Blood glucose increased
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Cardiac disorders
Bradycardia
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Reproductive system and breast disorders
Breast cancer
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.91%
3/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis viral
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Cardiac disorders
Cardiac arrest
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Cardiac disorders
Cardiac failure congestive
|
5.5%
18/330
|
1.6%
4/256
|
1.2%
3/254
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Cardiac disorders
Cardiomyopathy
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Vascular disorders
Carotid artery occlusion
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Eye disorders
Cataract
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.2%
4/330
|
0.78%
2/256
|
0.39%
1/254
|
|
Vascular disorders
Cerebrovascular accident
|
2.1%
7/330
|
0.78%
2/256
|
0.39%
1/254
|
|
General disorders
Chest pain
|
2.7%
9/330
|
0.39%
1/256
|
1.2%
3/254
|
|
Hepatobiliary disorders
Cholecystitis
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.61%
2/330
|
0.00%
0/256
|
0.79%
2/254
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonoscopy abnormal
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Colostomy closure
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Compression fracture
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
General disorders
Convulsion
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Vascular disorders
Coronary arterial stent insertion
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Cardiac disorders
Coronary artery disease
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Gastrointestinal disorders
Crohn's disease
|
0.61%
2/330
|
0.00%
0/256
|
0.79%
2/254
|
|
General disorders
Death
|
2.7%
9/330
|
0.39%
1/256
|
0.39%
1/254
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
General disorders
Dehydration
|
0.61%
2/330
|
0.00%
0/256
|
0.79%
2/254
|
|
Psychiatric disorders
Dementia
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Endocrine disorders
Diabetes mellitus
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Endocrine disorders
Diabetic coma
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Endocrine disorders
Diabetic complications
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Eye disorders
Diabetic retinopathy
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Dialysis
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Gastrointestinal disorders
Diverticulitis
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Gastrointestinal disorders
Diverticulum
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
General disorders
Dizziness
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
9/330
|
0.78%
2/256
|
0.79%
2/254
|
|
Vascular disorders
Endarterectomy
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Reproductive system and breast disorders
Epididymitis
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Infections and infestations
Erysipelas
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
General disorders
Fall
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Gastrointestinal disorders
Gastric bypass
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.61%
2/330
|
0.00%
0/256
|
0.79%
2/254
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Gastrointestinal disorders
Gastrointestinal infection
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Gastrointestinal disorders
Gastrointestinal injury
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
General disorders
Generalised oedema
|
0.61%
2/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Vascular disorders
Haematoma
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.61%
2/330
|
0.00%
0/256
|
0.39%
1/254
|
|
General disorders
Head injury
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Headache
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Cardiac disorders
Heart rate increased
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Cardiac disorders
Heart rate irregular
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Hernia
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
1.5%
5/330
|
0.00%
0/256
|
0.79%
2/254
|
|
Musculoskeletal and connective tissue disorders
Humerus fracture
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Nervous system disorders
Hydrocephalus
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Hyperglycaemia
|
0.61%
2/330
|
0.39%
1/256
|
0.00%
0/254
|
|
General disorders
Hyperkalaemia
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Endocrine disorders
Hyperparathyroidism
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Hypoglycaemia
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Hypoxia
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Vascular disorders
Iliac artery stenosis
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Intermittent claudication
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Kidney infection
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Knee arthroplasty
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Limb injury
|
0.61%
2/330
|
0.39%
1/256
|
0.39%
1/254
|
|
Surgical and medical procedures
Limb operation
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Infections and infestations
Localised infection
|
1.5%
5/330
|
1.2%
3/256
|
0.39%
1/254
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Meniscus lesion
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Psychiatric disorders
Mental disorder
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Surgical and medical procedures
Metatarsal excision
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Cardiac disorders
Myocardial infarction
|
4.8%
16/330
|
0.78%
2/256
|
1.2%
3/254
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
General disorders
oedema
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Oedema peripheral
|
0.61%
2/330
|
0.78%
2/256
|
0.00%
0/254
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.61%
2/330
|
0.78%
2/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.91%
3/330
|
0.39%
1/256
|
0.39%
1/254
|
|
Reproductive system and breast disorders
Ovarian cancer
|
0.61%
2/330
|
0.78%
2/256
|
0.00%
0/254
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Pain in extremity
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Pelvic fracture
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.0%
10/330
|
0.78%
2/256
|
0.39%
1/254
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia bacterial
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Infections and infestations
Post procedural infection
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Reproductive system and breast disorders
Prostate examination abnormal
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Infections and infestations
Pseudomonas infection
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Psychiatric disorders
Psychotic disorder
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Vascular disorders
Pulmonary embolism
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Vascular disorders
Pulmonary oedema
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Cardiac disorders
Pulse absent
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Vascular disorders
Rectal haemorrhage
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Renal disorder
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Renal failure
|
1.8%
6/330
|
0.78%
2/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Renal failure acute
|
0.91%
3/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Renal failure chronic
|
0.61%
2/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Renal and urinary disorders
Renal impairment
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Renal transplant
|
0.61%
2/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Renal and urinary disorders
Renal vessel disorder
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Infections and infestations
Septic shock
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
General disorders
Shunt malfunction
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Infections and infestations
Skin bacterial infection
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Surgical and medical procedures
Skin lesion excision
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.61%
2/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Musculoskeletal and connective tissue disorders
Spinal compression fracture
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Surgical and medical procedures
Stent placement
|
0.61%
2/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Surgical and medical procedures
Surgical vascular shunt
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
General disorders
Tobacco abuse
|
0.30%
1/330
|
0.00%
0/256
|
0.39%
1/254
|
|
Surgical and medical procedures
Toe amputation
|
1.5%
5/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Cardiac disorders
Transient ischaemic attack
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Urinary incontinence
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Renal and urinary disorders
Urinary tract infection
|
0.61%
2/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Psychiatric disorders
Vascular dementia
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
General disorders
Vertigo
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Eye disorders
Visual acuity reduced
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Surgical and medical procedures
Vitrectomy
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Eye disorders
Vitreous floaters
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
|
Infections and infestations
Volvulus
|
0.30%
1/330
|
0.39%
1/256
|
0.00%
0/254
|
|
Infections and infestations
Wound infection staphylococcal
|
0.30%
1/330
|
0.00%
0/256
|
0.00%
0/254
|
Other adverse events
| Measure |
Focal/Grid Laser Photocoagulation
n=330 participants at risk
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
|
1mg Intravitreal Triamcinolone
n=256 participants at risk
Intravitreal injection of 1mg of triamcinolone acetonide
|
4 mg Intravitreal Triamcinolone
n=254 participants at risk
Intravitreal injection of 4mg of triamcinolone acetonide
|
|---|---|---|---|
|
Eye disorders
Anterior Chamber Cell
|
0.30%
1/330
|
5.5%
14/256
|
3.5%
9/254
|
|
Eye disorders
Cataract
|
11.5%
38/330
|
11.3%
29/256
|
22.4%
57/254
|
|
Eye disorders
Cataract Cortical
|
5.8%
19/330
|
8.6%
22/256
|
12.6%
32/254
|
|
Eye disorders
Cataract Nuclear
|
3.9%
13/330
|
11.7%
30/256
|
15.0%
38/254
|
|
Eye disorders
Cataract Operation
|
4.2%
14/330
|
6.2%
16/256
|
12.2%
31/254
|
|
Eye disorders
Cataract Subcapsular
|
8.8%
29/330
|
21.1%
54/256
|
29.5%
75/254
|
|
Eye disorders
Conjunctival Hemorrhage
|
2.1%
7/330
|
37.5%
96/256
|
41.3%
105/254
|
|
Eye disorders
Diabetic Retinopathy
|
3.6%
12/330
|
5.1%
13/256
|
2.0%
5/254
|
|
Eye disorders
Dry Eye
|
3.0%
10/330
|
5.1%
13/256
|
3.9%
10/254
|
|
Eye disorders
Eye Irritation
|
0.61%
2/330
|
4.7%
12/256
|
5.9%
15/254
|
|
Eye disorders
Eye Pain
|
3.3%
11/330
|
10.9%
28/256
|
13.0%
33/254
|
|
Eye disorders
Eye Pruritus
|
2.7%
9/330
|
5.5%
14/256
|
4.3%
11/254
|
|
Eye disorders
Foreign body in the eye
|
1.2%
4/330
|
23.8%
61/256
|
20.1%
51/254
|
|
Eye disorders
Intraocular Pressure increased
|
4.2%
14/330
|
19.5%
50/256
|
38.2%
97/254
|
|
Eye disorders
Lacrimation increased
|
2.7%
9/330
|
7.4%
19/256
|
6.3%
16/254
|
|
Eye disorders
Maculopathy
|
7.0%
23/330
|
12.1%
31/256
|
12.2%
31/254
|
|
Eye disorders
Vision Blurred
|
10.9%
36/330
|
17.2%
44/256
|
18.9%
48/254
|
|
Eye disorders
Visual acuity reduced
|
14.2%
47/330
|
15.6%
40/256
|
20.1%
51/254
|
|
Eye disorders
Visual disturbance
|
4.5%
15/330
|
9.0%
23/256
|
8.7%
22/254
|
|
Eye disorders
Vitreous Detachment
|
4.8%
16/330
|
5.1%
13/256
|
2.8%
7/254
|
|
Eye disorders
Vitreous floaters
|
10.9%
36/330
|
35.9%
92/256
|
38.6%
98/254
|
|
Eye disorders
Vitrous Hemorrhage
|
14.8%
49/330
|
16.8%
43/256
|
12.6%
32/254
|
|
Blood and lymphatic system disorders
Anaemia
|
6.4%
21/330
|
9.4%
24/256
|
5.1%
13/254
|
|
Cardiac disorders
Cardiac Failure Congestive
|
5.8%
19/330
|
6.6%
17/256
|
5.5%
14/254
|
|
General disorders
Dysonoea
|
4.5%
15/330
|
5.1%
13/256
|
6.3%
16/254
|
|
General disorders
Headache
|
4.5%
15/330
|
4.3%
11/256
|
7.9%
20/254
|
|
Blood and lymphatic system disorders
Hypercholesterolaemia
|
3.3%
11/330
|
2.3%
6/256
|
5.1%
13/254
|
|
Cardiac disorders
Hypertension
|
5.2%
17/330
|
5.9%
15/256
|
8.3%
21/254
|
|
General disorders
Oedema peripheral
|
4.2%
14/330
|
5.1%
13/256
|
3.1%
8/254
|
|
Renal and urinary disorders
Renal failure
|
4.2%
14/330
|
5.1%
13/256
|
3.1%
8/254
|
Additional Information
Adam R. Glassman, Director DRCR.net Coordinating Center
Jaeb Center for Health Research
Phone: 813-975-8690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place