Trial Outcomes & Findings for Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N) (NCT NCT00996437)
NCT ID: NCT00996437
Last Updated: 2016-08-26
Results Overview
The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
261 participants
Primary outcome timeframe
within 112 days of randomization
Results posted on
2016-08-26
Participant Flow
Participant milestones
| Measure |
Ranibizumab
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
136
|
|
Overall Study
COMPLETED
|
120
|
129
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Ranibizumab
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Dropped
|
2
|
2
|
|
Overall Study
Missed
|
2
|
5
|
Baseline Characteristics
Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)
Baseline characteristics by cohort
| Measure |
Ranibizumab
n=125 Participants
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 Participants
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
Total
n=261 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Duration of vitreous hemorrhage since first documented on clinical exam
< 1month
|
66 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Age, Customized
|
61 years
n=5 Participants
|
58 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
67 participants
n=5 Participants
|
70 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
32 participants
n=5 Participants
|
34 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Duration of vitreous hemorrhage since first documented on clinical exam
1-3 months
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/not reported
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Diabetes Type
Type1
|
21 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Diabetes Type
Type 2
|
101 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Diabetes Type
Uncertain
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Duration of vitreous hemorrhage since first documented on clinical exam
4-6 months
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Duration of Diabetes (years)
|
19 Number
n=5 Participants
|
21 Number
n=7 Participants
|
20 Number
n=5 Participants
|
|
Hemoglobin A1c
|
7.7 Percentage
n=5 Participants
|
8.0 Percentage
n=7 Participants
|
7.9 Percentage
n=5 Participants
|
|
Pre-Existing Cardiovascular Conditions
Yes
|
44 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Pre-Existing Cardiovascular Conditions
No
|
81 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Pre-Existing Hypertension
Yes
|
105 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Pre-Existing Hypertension
No
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Prior panretinal photocoagulation
Yes
|
62 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Prior panretinal photocoagulation
No
|
63 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Prior Treatment for Diabetic Macular Edema
Yes
|
53 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Prior Treatment for Diabetic Macular Edema
No
|
72 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Prior treatment with anti-vascular endothelial growth factor drug for diabetic macular edema
Yes
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Prior treatment with anti-vascular endothelial growth factor drug for diabetic macular edema
No
|
115 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Lens Status (on clinical exam)
Phakic
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Lens Status (on clinical exam)
Posterior Chamber Intraocular Lens
|
28 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Optical coherence tomography signal strength
=0
|
74 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Optical coherence tomography signal strength
> 0
|
50 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Optical coherence tomography signal strength
Missing/not available
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ultrasound completed to assess eligibility
Yes
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ultrasound completed to assess eligibility
No
|
63 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Duration of vitreous hemorrhage since first documented on clinical exam
> 6 months
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Median Electronic-Early Treatment Diabetic Retinopathy Visual Acuity (letter score)
|
34 Units on a scale
n=5 Participants
|
28 Units on a scale
n=7 Participants
|
31 Units on a scale
n=5 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score
> 69 letter score - (20/40 or better)
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score
68 to 49 letter score - (20/50 to 20/100)
|
32 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score
48 to 24 letter score - (20/125 to 20/320)
|
18 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score
23 to 1 letter score - (20/400 to 20/800-3)
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score
Counting fingers only
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score
Hand motion only
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score
Light perception only
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score
No light perception
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Intraocular Pressure
|
15 mm Hg
n=5 Participants
|
14 mm Hg
n=7 Participants
|
15 mm Hg
n=5 Participants
|
|
Anti-platelet aggregation and anti-coagulant drugs
Aspirin
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Anti-platelet aggregation and anti-coagulant drugs
Other anti-platelet aggregation drugs
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Anti-platelet aggregation and anti-coagulant drugs
Anti-coagulants
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Anti-platelet aggregation and anti-coagulant drugs
NSAIDs
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Anti-platelet aggregation and anti-coagulant drugs
Not Available
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 112 days of randomizationPopulation: The primary analysis followed the intent-to-treat principle and included all randomized eyes.
The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.
Outcome measures
| Measure |
Ranibizumab
n=125 Participants
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 Participants
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Treatment or "Failure" Defined as Vitrectomy
|
12 percentage of participants
|
17 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to 16 weeksPopulation: Adverse events for each participants was collected throughout study duration.
Outcome measures
| Measure |
Ranibizumab
n=125 Participants
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 Participants
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Endophthalmitis
|
0 participants
|
1 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Traction and/or rhegmatogeneous retinal detachment
|
10 participants
|
11 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Angle or iris neovascularization
|
1 participants
|
4 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Neovascular glaucoma
|
1 participants
|
1 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Cataract Surgery
|
0 participants
|
2 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Recurrent vitreous hemorrhage on clinical exam
|
8 participants
|
23 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Elevated Intraocular Pressure (IOP)/Glaucoma
|
16 participants
|
19 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Increase of IOP >= 10 mm Hg from baseline
|
8 participants
|
11 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
IOP >= 30 mm Hg
|
4 participants
|
4 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Currently on IOP-lowering medication, not baseline
|
13 participants
|
14 participants
|
|
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
Glaucoma surgery at anytime
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: within 112 days of randomizationPopulation: The secondary analysis followed the intent-to-treat principle and included all randomized eyes.
The proportion of eyes with "complete" panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test.
Outcome measures
| Measure |
Ranibizumab
n=125 Participants
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 Participants
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy
|
44 percentage of eyes
|
31 percentage of eyes
|
SECONDARY outcome
Timeframe: 4, 8 and 12 weeksPopulation: This analysis followed the intent-to-treat principle
Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.
Outcome measures
| Measure |
Ranibizumab
n=125 Participants
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 Participants
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength
4 week results
|
40 percentage of eyes
|
28 percentage of eyes
|
|
Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength
8 week results
|
46 percentage of eyes
|
38 percentage of eyes
|
|
Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength
12 week results
|
51 percentage of eyes
|
52 percentage of eyes
|
SECONDARY outcome
Timeframe: 4, 8 and 12 weeksPopulation: Number of participants with a complete 4 week visit, 8 and 12 week respectively and an available visual acuity measurement.
Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.
Outcome measures
| Measure |
Ranibizumab
n=125 Participants
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 Participants
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status
4 week results
|
45 letter scores
Standard Deviation 30
|
42 letter scores
Standard Deviation 31
|
|
Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status
8 week results
|
51 letter scores
Standard Deviation 30
|
47 letter scores
Standard Deviation 31
|
|
Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status
12 week results
|
57 letter scores
Standard Deviation 27
|
49 letter scores
Standard Deviation 29
|
SECONDARY outcome
Timeframe: 4, 8 and 12 weeksPopulation: This analysis followed the intent-to-treat principle. It includes all randomized eyes with a completed 4, 8 and 12 week visit respectively and an available visual acuity measure.
Outcome measures
| Measure |
Ranibizumab
n=125 Participants
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 Participants
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit
4 week results
|
29 percentage of participants
|
29 percentage of participants
|
|
Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit
8 week results
|
36 percentage of participants
|
33 percentage of participants
|
|
Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit
12 week results
|
45 percentage of participants
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: 4,8 and 12 weeksPopulation: Participant with a completed 4,8 and 12 week visit and an available visual acuity measurement were included in this analysis.
Outcome measures
| Measure |
Ranibizumab
n=125 Participants
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 Participants
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Severe Visual Acuity Loss (Defined as <20/200)
12 week results
|
20 percentage of participants
|
27 percentage of participants
|
|
Severe Visual Acuity Loss (Defined as <20/200)
4 week results
|
38 percentage of participants
|
38 percentage of participants
|
|
Severe Visual Acuity Loss (Defined as <20/200)
8 week results
|
30 percentage of participants
|
35 percentage of participants
|
SECONDARY outcome
Timeframe: 4,8 and 12 weeksPopulation: Participants with a completed 4, 8 and 12 week visit respectively and an available visual acuity measurement were included in the analysis.
Outcome measures
| Measure |
Ranibizumab
n=125 Participants
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 Participants
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Very Severe Visual Acuity Loss (Defined as <20/800)
4 week results
|
20 percentage of participants
|
25 percentage of participants
|
|
Very Severe Visual Acuity Loss (Defined as <20/800)
8 week results
|
16 percentage of participants
|
19 percentage of participants
|
|
Very Severe Visual Acuity Loss (Defined as <20/800)
12 week results
|
11 percentage of participants
|
16 percentage of participants
|
Adverse Events
Ranibizumab
Serious events: 13 serious events
Other events: 84 other events
Deaths: 0 deaths
Saline Injection
Serious events: 23 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab
n=125 participants at risk
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 participants at risk
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Eye disorders
Endophthalmitis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
2.4%
3/125 • Number of events 3
|
2.9%
4/136 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Cardiac disorders
Congestive cardiac failure
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Cardiac disorders
Cardiomegaly
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
General disorders
Chest pain
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
General disorders
Death
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Psychiatric disorders
Depression
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Vascular disorders
Diabetic foot
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Endocrine disorders
Diabetic gastroparesis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/125
|
2.2%
3/136 • Number of events 3
|
|
Endocrine disorders
Hypoglycaemia
|
0.00%
0/125
|
1.5%
2/136 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Renal and urinary disorders
Renal Faliure
|
0.00%
0/125
|
1.5%
2/136 • Number of events 2
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Retinal Tear
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Vascular disorders
Transient ishaemic attack
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Upper limb fracture
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
Other adverse events
| Measure |
Ranibizumab
n=125 participants at risk
Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
|
Saline Injection
n=136 participants at risk
Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
|
|---|---|---|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Ear and labyrinth disorders
Otitis media acute
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/125
|
1.5%
2/136 • Number of events 2
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
2/125 • Number of events 2
|
2.2%
3/136 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Anterior chamber cell
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Anterior chamber flare
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Aphkia
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Vascular disorders
Arteriovenous fistula
|
1.6%
2/125 • Number of events 2
|
0.74%
1/136 • Number of events 1
|
|
Hepatobiliary disorders
Ascites
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Cardiac disorders
Atrial fibrilliation
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.80%
1/125 • Number of events 1
|
1.5%
2/136 • Number of events 2
|
|
Eye disorders
Blepharitis
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Investigations
Blood potasium increased
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Borderline glaucoma
|
0.80%
1/125 • Number of events 1
|
1.5%
2/136 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Cardiac disorders
Cardiomegaly
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Cataract
|
4.0%
5/125 • Number of events 5
|
5.1%
7/136 • Number of events 7
|
|
Eye disorders
Cataract cortical
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Cataract nuclear
|
1.6%
2/125 • Number of events 3
|
0.00%
0/136
|
|
Eye disorders
Cataract operation complication
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Cataract subcapsular
|
1.6%
2/125 • Number of events 2
|
2.2%
3/136 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
General disorders
Chest pain
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Choroidal detachment
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonic polyp
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Conjunctival hemorrhage
|
5.6%
7/125 • Number of events 11
|
5.1%
7/136 • Number of events 10
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/125
|
1.5%
2/136 • Number of events 3
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
General disorders
Constipation
|
1.6%
2/125 • Number of events 2
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Corneal abrasion
|
1.6%
2/125 • Number of events 3
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Corneal defect
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
4/125 • Number of events 4
|
2.9%
4/136 • Number of events 4
|
|
Infections and infestations
Cystitis
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Endocrine disorders
Diabetes mellitus inadequate control
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Vascular disorders
Diabetic foot
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Diabetic retinal oedema
|
2.4%
3/125 • Number of events 3
|
2.2%
3/136 • Number of events 3
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
5/125 • Number of events 5
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Nervous system disorders
Dizziness
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Infections and infestations
Ear infection
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Eye discharge
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Eye irritation
|
2.4%
3/125 • Number of events 4
|
2.2%
3/136 • Number of events 4
|
|
Eye disorders
Eye pain
|
11.2%
14/125 • Number of events 18
|
10.3%
14/136 • Number of events 15
|
|
Eye disorders
Eye pruritus
|
0.80%
1/125 • Number of events 1
|
2.2%
3/136 • Number of events 6
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
General disorders
Facial pain
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
2/125 • Number of events 2
|
0.74%
1/136 • Number of events 1
|
|
General disorders
Fatigue
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Foreign body sensation in eyes
|
2.4%
3/125 • Number of events 3
|
0.00%
0/136
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Glaucoma
|
1.6%
2/125 • Number of events 2
|
2.9%
4/136 • Number of events 4
|
|
Nervous system disorders
Headache
|
0.00%
0/125
|
6.6%
9/136 • Number of events 9
|
|
Infections and infestations
Herpes Zoster
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Hordeolum
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Endocrine disorders
Hyperglycaemia
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.4%
3/125 • Number of events 3
|
2.9%
4/136 • Number of events 4
|
|
Eye disorders
Hyphaema
|
1.6%
2/125 • Number of events 2
|
0.00%
0/136
|
|
Endocrine disorders
Hypoglycaemia
|
0.00%
0/125
|
2.2%
3/136 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Endocrine disorders
Hypthyroidism
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/125
|
1.5%
2/136 • Number of events 2
|
|
Investigations
Intra ocular pressure increased
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Iris neovascularization
|
0.00%
0/125
|
2.2%
3/136 • Number of events 3
|
|
Eye disorders
Irititis
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Keratitis
|
1.6%
2/125 • Number of events 2
|
0.00%
0/136
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
3.2%
4/125 • Number of events 4
|
1.5%
2/136 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.6%
2/125 • Number of events 2
|
0.00%
0/136
|
|
Infections and infestations
Localised infection
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Macular cyst
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Macular fibrosis
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Macular ischaemia
|
0.00%
0/125
|
0.74%
1/136 • Number of events 2
|
|
Eye disorders
Mascular oedema
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Maculopathy
|
4.0%
5/125 • Number of events 5
|
1.5%
2/136 • Number of events 2
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Investigations
Mammogram abnormal
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Metamorphosia
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Musculoskeletal and connective tissue disorders
Multiple fractures
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Nervous system disorders
Muscular weakness
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
4.0%
5/125 • Number of events 5
|
2.9%
4/136 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
6.4%
8/125 • Number of events 10
|
1.5%
2/136 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/125
|
2.2%
3/136 • Number of events 3
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Night blindness
|
0.00%
0/125
|
0.74%
1/136 • Number of events 2
|
|
Eye disorders
Ocular discomfort
|
1.6%
2/125 • Number of events 2
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/125
|
1.5%
2/136 • Number of events 2
|
|
Eye disorders
Ocular hypertension
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/125
|
2.9%
4/136 • Number of events 5
|
|
Eye disorders
Optic atrophy
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/125
|
2.2%
3/136 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/125
|
2.2%
3/136 • Number of events 3
|
|
Nervous system disorders
Parkison's disease
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Photophobia
|
0.80%
1/125 • Number of events 2
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Photopsia
|
3.2%
4/125 • Number of events 6
|
2.2%
3/136 • Number of events 5
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/125
|
1.5%
2/136 • Number of events 3
|
|
General disorders
Pyrexia
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Renal and urinary disorders
Renal imparment
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Retinal aneurysm
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Retinal detachment
|
4.8%
6/125 • Number of events 7
|
5.1%
7/136 • Number of events 7
|
|
Eye disorders
Retinal disorder
|
0.00%
0/125
|
1.5%
2/136 • Number of events 2
|
|
Eye disorders
Retinal haemorrhage
|
0.80%
1/125 • Number of events 1
|
1.5%
2/136 • Number of events 2
|
|
Eye disorders
Retinal neovascularization
|
0.00%
0/125
|
2.9%
4/136 • Number of events 5
|
|
Eye disorders
Retinal tear
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.6%
2/125 • Number of events 2
|
0.00%
0/136
|
|
Infections and infestations
Skin infection
|
0.00%
0/125
|
1.5%
2/136 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/125
|
1.5%
2/136 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
4/125 • Number of events 4
|
2.2%
3/136 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Immune system disorders
Urticaria
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Nervous system disorders
Vertigo
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Vision blurred
|
6.4%
8/125 • Number of events 10
|
8.1%
11/136 • Number of events 12
|
|
Eye disorders
Visual acuity reduced
|
4.8%
6/125 • Number of events 6
|
5.1%
7/136 • Number of events 7
|
|
Eye disorders
Visual field defect
|
0.80%
1/125 • Number of events 2
|
0.00%
0/136
|
|
Eye disorders
Visual impairment
|
4.0%
5/125 • Number of events 7
|
1.5%
2/136 • Number of events 2
|
|
Eye disorders
Vitreous detachment
|
0.80%
1/125 • Number of events 1
|
0.00%
0/136
|
|
Eye disorders
Vitreous disorder
|
0.80%
1/125 • Number of events 1
|
0.74%
1/136 • Number of events 1
|
|
Eye disorders
Vitreous floaters
|
11.2%
14/125 • Number of events 15
|
8.1%
11/136 • Number of events 14
|
|
Eye disorders
Vitreous hemorrhage
|
12.8%
16/125 • Number of events 17
|
14.7%
20/136 • Number of events 25
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/125 • Number of events 2
|
0.74%
1/136 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/125
|
0.74%
1/136 • Number of events 1
|
Additional Information
Adam R. Glassman
Diabetic Retinopathy Clinical Research Network
Phone: 813-975-8761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place