Trial Outcomes & Findings for Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy (NCT NCT00445003)
NCT ID: NCT00445003
Last Updated: 2016-08-26
Results Overview
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
333 participants
Primary outcome timeframe
baseline to 14 weeks
Results posted on
2016-08-26
Participant Flow
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
Participants with 2 study eyes enrolled each eye in a different arm. Each treatment arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
Participant milestones
| Measure |
Sham Injection
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
123
|
113
|
109
|
|
Overall Study
COMPLETED
|
118
|
103
|
105
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
4
|
Reasons for withdrawal
| Measure |
Sham Injection
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
1
|
|
Overall Study
Missed Visit
|
3
|
5
|
1
|
|
Overall Study
Dropped
|
1
|
3
|
2
|
Baseline Characteristics
Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
Baseline characteristics by cohort
| Measure |
Sham Injection
n=123 Participants
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=113 Participants
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=109 Participants
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
Total
n=345 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
54 years
n=5 Participants
|
57 years
n=7 Participants
|
58 years
n=5 Participants
|
56 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
18 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
76 participants
n=5 Participants
|
72 participants
n=7 Participants
|
61 participants
n=5 Participants
|
209 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
31 participants
n=5 Participants
|
23 participants
n=7 Participants
|
27 participants
n=5 Participants
|
81 participants
n=4 Participants
|
|
Optical coherence tomography subretinal fluid present (questionable or definite)
Yes
|
30 Eyes
n=5 Participants
|
31 Eyes
n=7 Participants
|
32 Eyes
n=5 Participants
|
93 Eyes
n=4 Participants
|
|
Optical coherence tomography subretinal fluid present (questionable or definite)
No
|
93 Eyes
n=5 Participants
|
82 Eyes
n=7 Participants
|
77 Eyes
n=5 Participants
|
252 Eyes
n=4 Participants
|
|
Classification of diabetic macular edema on clinical exam
Predominantly Focal'
|
37 Eyes
n=5 Participants
|
19 Eyes
n=7 Participants
|
27 Eyes
n=5 Participants
|
83 Eyes
n=4 Participants
|
|
Classification of diabetic macular edema on clinical exam
Neither perdominantly focal or diffuse
|
18 Eyes
n=5 Participants
|
25 Eyes
n=7 Participants
|
14 Eyes
n=5 Participants
|
57 Eyes
n=4 Participants
|
|
Classification of diabetic macular edema on clinical exam
Predominantly diffuse
|
68 Eyes
n=5 Participants
|
69 Eyes
n=7 Participants
|
68 Eyes
n=5 Participants
|
205 Eyes
n=4 Participants
|
|
Intraocular Pressure
|
15 mmHg
n=5 Participants
|
16 mmHg
n=7 Participants
|
15 mmHg
n=5 Participants
|
15 mmHg
n=4 Participants
|
|
Diabetes Type
Type 1
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Diabetes Type
Type 2
|
101 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
|
Diabetes Type
Uncertain
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Duration of diabetes
|
15 Years
n=5 Participants
|
15 Years
n=7 Participants
|
15 Years
n=5 Participants
|
15 Years
n=4 Participants
|
|
Hemoglobin A1c
|
7.9 Percentage
n=5 Participants
|
8.1 Percentage
n=7 Participants
|
8.1 Percentage
n=5 Participants
|
8.0 Percentage
n=4 Participants
|
|
Prior Cardiovascular event
Yes
|
21 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Prior Cardiovascular event
No
|
102 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
261 Participants
n=4 Participants
|
|
Hypertension
Yes
|
97 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
267 Participants
n=4 Participants
|
|
Hypertension
No
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Number of study eyes
1 study eye
|
97 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
293 Participants
n=4 Participants
|
|
Number of study eyes
2 study eyes
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Prior Panretinal scatter photocoagulation
Yes
|
16 Eyes
n=5 Participants
|
20 Eyes
n=7 Participants
|
19 Eyes
n=5 Participants
|
55 Eyes
n=4 Participants
|
|
Prior Panretinal scatter photocoagulation
No
|
107 Eyes
n=5 Participants
|
93 Eyes
n=7 Participants
|
90 Eyes
n=5 Participants
|
290 Eyes
n=4 Participants
|
|
prior treatment for diabetic macular edema
Yes
|
80 Eyes
n=5 Participants
|
75 Eyes
n=7 Participants
|
72 Eyes
n=5 Participants
|
227 Eyes
n=4 Participants
|
|
prior treatment for diabetic macular edema
No
|
43 Eyes
n=5 Participants
|
38 Eyes
n=7 Participants
|
37 Eyes
n=5 Participants
|
118 Eyes
n=4 Participants
|
|
Prior laser for diabetic macular edema
Yes
|
40 Eyes
n=5 Participants
|
33 Eyes
n=7 Participants
|
36 Eyes
n=5 Participants
|
109 Eyes
n=4 Participants
|
|
Prior laser for diabetic macular edema
No
|
83 Eyes
n=5 Participants
|
80 Eyes
n=7 Participants
|
73 Eyes
n=5 Participants
|
236 Eyes
n=4 Participants
|
|
Prior intravitreal triamcinolone for diabetic macular edema
Yes
|
1 Eyes
n=5 Participants
|
9 Eyes
n=7 Participants
|
3 Eyes
n=5 Participants
|
13 Eyes
n=4 Participants
|
|
Prior intravitreal triamcinolone for diabetic macular edema
No
|
122 Eyes
n=5 Participants
|
104 Eyes
n=7 Participants
|
106 Eyes
n=5 Participants
|
332 Eyes
n=4 Participants
|
|
Prior vitrectomy for diabetic macular edema
Yes
|
2 Eyes
n=5 Participants
|
0 Eyes
n=7 Participants
|
0 Eyes
n=5 Participants
|
2 Eyes
n=4 Participants
|
|
Prior vitrectomy for diabetic macular edema
No
|
121 Eyes
n=5 Participants
|
113 Eyes
n=7 Participants
|
109 Eyes
n=5 Participants
|
343 Eyes
n=4 Participants
|
|
Prior peribulbar triamcinolone for diabetic macular edema
Yes
|
1 Eyes
n=5 Participants
|
0 Eyes
n=7 Participants
|
1 Eyes
n=5 Participants
|
2 Eyes
n=4 Participants
|
|
Prior peribulbar triamcinolone for diabetic macular edema
No
|
122 Eyes
n=5 Participants
|
113 Eyes
n=7 Participants
|
108 Eyes
n=5 Participants
|
343 Eyes
n=4 Participants
|
|
prior anti- vascular endothelial growth factor for diabetic macular edema
Yes
|
6 Eyes
n=5 Participants
|
1 Eyes
n=7 Participants
|
3 Eyes
n=5 Participants
|
10 Eyes
n=4 Participants
|
|
prior anti- vascular endothelial growth factor for diabetic macular edema
No
|
117 Eyes
n=5 Participants
|
112 Eyes
n=7 Participants
|
106 Eyes
n=5 Participants
|
335 Eyes
n=4 Participants
|
|
Currently on intraocular pressure lowering medication for glaucoma or ocular hypertension
Yes
|
0 Eyes
n=5 Participants
|
3 Eyes
n=7 Participants
|
0 Eyes
n=5 Participants
|
3 Eyes
n=4 Participants
|
|
Currently on intraocular pressure lowering medication for glaucoma or ocular hypertension
No
|
123 Eyes
n=5 Participants
|
110 Eyes
n=7 Participants
|
109 Eyes
n=5 Participants
|
342 Eyes
n=4 Participants
|
|
Lens status (clinical examination)
Phakic
|
111 Eyes
n=5 Participants
|
91 Eyes
n=7 Participants
|
99 Eyes
n=5 Participants
|
301 Eyes
n=4 Participants
|
|
Lens status (clinical examination)
Pseudophakic
|
12 Eyes
n=5 Participants
|
22 Eyes
n=7 Participants
|
10 Eyes
n=5 Participants
|
44 Eyes
n=4 Participants
|
|
Baseline visual acuity by randomization strata
|
67 Letter Score
n=5 Participants
|
68 Letter Score
n=7 Participants
|
67 Letter Score
n=5 Participants
|
67 Letter Score
n=4 Participants
|
|
Central subfield thickness on optical coherence tomography
|
355 Microns
n=5 Participants
|
352 Microns
n=7 Participants
|
359 Microns
n=5 Participants
|
355 Microns
n=4 Participants
|
|
Retinal volume on optical coherence tomography
|
9.4 cubic millimetre
n=5 Participants
|
9.2 cubic millimetre
n=7 Participants
|
9.1 cubic millimetre
n=5 Participants
|
9.2 cubic millimetre
n=4 Participants
|
|
Optical coherence tomography cystoid abnormality (questionable or definite)
Yes
|
108 Eyes
n=5 Participants
|
96 Eyes
n=7 Participants
|
96 Eyes
n=5 Participants
|
300 Eyes
n=4 Participants
|
|
Optical coherence tomography cystoid abnormality (questionable or definite)
No
|
15 Eyes
n=5 Participants
|
17 Eyes
n=7 Participants
|
13 Eyes
n=5 Participants
|
45 Eyes
n=4 Participants
|
|
Early Treatment Diabetic Retinopath Study Retinopathy severity level from photograph grading
Level 35, 43 (Mild/Moderate NPDR)
|
6 Eyes
n=5 Participants
|
5 Eyes
n=7 Participants
|
6 Eyes
n=5 Participants
|
17 Eyes
n=4 Participants
|
|
Early Treatment Diabetic Retinopath Study Retinopathy severity level from photograph grading
Level 47 (Moderately severe NPDR)
|
26 Eyes
n=5 Participants
|
15 Eyes
n=7 Participants
|
10 Eyes
n=5 Participants
|
51 Eyes
n=4 Participants
|
|
Early Treatment Diabetic Retinopath Study Retinopathy severity level from photograph grading
Level 53 (Severe NPDR)
|
5 Eyes
n=5 Participants
|
6 Eyes
n=7 Participants
|
5 Eyes
n=5 Participants
|
16 Eyes
n=4 Participants
|
|
Early Treatment Diabetic Retinopath Study Retinopathy severity level from photograph grading
Level 60 (Prior PRP without active neovascularizat
|
2 Eyes
n=5 Participants
|
4 Eyes
n=7 Participants
|
3 Eyes
n=5 Participants
|
9 Eyes
n=4 Participants
|
|
Early Treatment Diabetic Retinopath Study Retinopathy severity level from photograph grading
Level 61 (Mild/Moderate PDR)
|
48 Eyes
n=5 Participants
|
36 Eyes
n=7 Participants
|
38 Eyes
n=5 Participants
|
122 Eyes
n=4 Participants
|
|
Early Treatment Diabetic Retinopath Study Retinopathy severity level from photograph grading
Level 71, 75 (High-risk PDR)
|
32 Eyes
n=5 Participants
|
43 Eyes
n=7 Participants
|
43 Eyes
n=5 Participants
|
118 Eyes
n=4 Participants
|
|
Early Treatment Diabetic Retinopath Study Retinopathy severity level from photograph grading
cannot grade
|
4 Eyes
n=5 Participants
|
4 Eyes
n=7 Participants
|
4 Eyes
n=5 Participants
|
12 Eyes
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline to 14 weeksPopulation: Participants with 2 study eyes enrolled each eye in a different arm. Each arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. Analysis followed intention to treat principle; eyes without 14-week data, the Last Observation Carried Forward method was used.
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Outcome measures
| Measure |
Sham Injection
n=123 Participants
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=113 Participants
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=109 Participants
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks
|
-4 Letter Score
Standard Deviation 14
|
1 Letter Score
Standard Deviation 11
|
2 Letter Score
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 14 weeks to 56-weeksEach combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.
Outcome measures
| Measure |
Sham Injection
n=123 Participants
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=113 Participants
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=109 Participants
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Additional Treatments for Diabetic Macular Edema
Bevacizumab
|
14 Eyes
|
12 Eyes
|
9 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Ranibizumab
|
1 Eyes
|
0 Eyes
|
3 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Triamcinolone
|
3 Eyes
|
8 Eyes
|
2 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Pegaptanib
|
0 Eyes
|
0 Eyes
|
3 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Laser
|
31 Eyes
|
10 Eyes
|
21 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Vitrectomy
|
2 Eyes
|
1 Eyes
|
0 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Bevacizumab plus Triamcinolone
|
2 Eyes
|
0 Eyes
|
2 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Ranibizumab plus Triamcinolone
|
0 Eyes
|
1 Eyes
|
0 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Bevacizumab plus laser
|
8 Eyes
|
5 Eyes
|
0 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Ranibizumab plus laser
|
0 Eyes
|
3 Eyes
|
0 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Triamcinolone plus laser
|
7 Eyes
|
4 Eyes
|
5 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Pegaptanib plus laser
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Triamcinolone plus vitrectomy
|
0 Eyes
|
1 Eyes
|
0 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Pegaptanib plus vitrectomy
|
0 Eyes
|
1 Eyes
|
0 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Triamcinolone plus laser plus vitrectomy
|
0 Eyes
|
1 Eyes
|
0 Eyes
|
|
Additional Treatments for Diabetic Macular Edema
Bevacizumab plus triamcinolone plus laser
|
2 Eyes
|
1 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: Baseline to 14 weeksPopulation: 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.
Outcome measures
| Measure |
Sham Injection
n=123 Participants
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=113 Participants
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=109 Participants
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Change in Optical Coherence Tomography Central Subfield Thickness
|
362 Microns
Interval 287.0 to 484.0
|
312 Microns
Interval 259.0 to 453.0
|
265 Microns
Interval 230.0 to 304.0
|
SECONDARY outcome
Timeframe: Baseline to 14-weeksPopulation: Participants with 2 study eyes enrolled each eye in a different arm. Therefore, each arm includes no more than 1 eye for a given participant, and thus the numbers of eyes is equal to number of participants.
Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.
Outcome measures
| Measure |
Sham Injection
n=69 Participants
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=66 Participants
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=66 Participants
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Total Optical Coherence Tomography Retinal Volume
|
9.7 mm^3
Standard Deviation 1.8
|
9.3 mm^3
Standard Deviation 1.9
|
7.9 mm^3
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: baseline to 56-weeksPopulation: 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.
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Outcome measures
| Measure |
Sham Injection
n=111 Participants
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=95 Participants
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=93 Participants
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Change in Visual Acuity From Baseline
|
-6 Letter Score
Standard Deviation 17
|
-4 Letter Score
Standard Deviation 21
|
-5 Letter Score
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 14 weeks to 56-weeksPopulation: 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.
Outcome measures
| Measure |
Sham Injection
n=123 Participants
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=113 Participants
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=109 Participants
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema
|
28 Eyes
|
23 Eyes
|
17 Eyes
|
SECONDARY outcome
Timeframe: 14 weeks to 56-weeksPopulation: 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.
Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments.
Outcome measures
| Measure |
Sham Injection
n=123 Participants
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=113 Participants
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=109 Participants
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema
|
71 Eyes
|
48 Eyes
|
45 Eyes
|
SECONDARY outcome
Timeframe: Baseline to 14 weeksPopulation: 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.
Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively
Outcome measures
| Measure |
Sham Injection
n=69 Participants
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=66 Participants
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=66 Participants
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Change in Optical Coherence Tomography Retinal Volume
|
0.1 mm^3
Standard Deviation 1.1
|
-0.4 mm^3
Standard Deviation 1.3
|
-1.3 mm^3
Standard Deviation 1.3
|
Adverse Events
Sham Injection
Serious events: 11 serious events
Other events: 57 other events
Deaths: 0 deaths
0.5mg Ranibizumab
Serious events: 15 serious events
Other events: 50 other events
Deaths: 0 deaths
4-mg Triamcinolone Acetonided
Serious events: 12 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Injection
n=133 participants at risk
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=116 participants at risk
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=115 participants at risk
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Cardiac disorders
Transient ischaemic attach
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Abdominal pain
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Cellulitis
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Cerebrovascular accident
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Chest pain
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Convulsion
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Surgical and medical procedures
Coronary arterial stant insertion
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Death
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Diabetes mellitus
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Cardiac disorders
Heart rate decreased
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Hypertension
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Ischaemic stroke
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Infections and infestations
Localised infection
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Nausea
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Endocrine disorders
Renal failure
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Eye disorders
Retinal detachment
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.86%
1/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Eye disorders
Vitreous haemorrhage
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
Vomiting
|
0.00%
0/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.87%
1/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
Other adverse events
| Measure |
Sham Injection
n=133 participants at risk
Sham injection at baseline and 4 weeks
|
0.5mg Ranibizumab
n=116 participants at risk
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
|
4-mg Triamcinolone Acetonided
n=115 participants at risk
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
1.5%
2/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
9.5%
11/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
7.0%
8/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Eye disorders
Eye pain
|
8.3%
11/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
6.0%
7/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
5.2%
6/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
General disorders
headache
|
5.3%
7/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
6.0%
7/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
4.3%
5/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Eye disorders
Intraocular pressure increase
|
0.75%
1/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
0.00%
0/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
9.6%
11/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Eye disorders
Myodesopsia
|
3.8%
5/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
6.0%
7/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
8.7%
10/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Eye disorders
Vision Blurred
|
9.8%
13/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
6.9%
8/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
7.8%
9/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Eye disorders
Vitreous floaters
|
2.3%
3/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
3.4%
4/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
8.7%
10/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
|
Eye disorders
Vitreous haemorrhage
|
11.3%
15/133 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
5.2%
6/116 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
6.1%
7/115 • Through 14-week Primary outcome visit
Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.
|
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
Restriction type: LTE60