Trial Outcomes & Findings for Efficacy & Safety Trial of Intravitreal Injections Combined With PRP for CSME Secondary to Diabetes Mellitus (DAVE) (NCT NCT01552408)
NCT ID: NCT01552408
Last Updated: 2018-10-05
Results Overview
Assess the number of ranibizumab injections in the ranibizumab and targeted panretinal photocoagulation (PRP) with ranibizumab cohorts through Month 36.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
36 Months
Results posted on
2018-10-05
Participant Flow
A total of 29 unique participants were enrolled in the study. 11 of these 29 had both eyes assigned to each intervention. Therefore, a total of 40 eyes were randomized in the trial.
Unit of analysis: Eyes
Participant milestones
| Measure |
0.3 mg Ranibizumab
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted Pan-retinal Photocoagulation With 0.3 mg Ranibizumab
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a pro re nata (PRN) schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Overall Study
STARTED
|
20 20
|
20 20
|
|
Overall Study
COMPLETED
|
16 16
|
18 18
|
|
Overall Study
NOT COMPLETED
|
4 4
|
2 2
|
Reasons for withdrawal
| Measure |
0.3 mg Ranibizumab
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted Pan-retinal Photocoagulation With 0.3 mg Ranibizumab
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a pro re nata (PRN) schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Relocation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
0.3 mg Ranibizumab
n=20 Eyes
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=20 Eyes
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
Total
n=40 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
55 years
n=20 Eyes
|
56 years
n=20 Eyes
|
55 years
n=40 Eyes
|
|
Sex/Gender, Customized
Gender : Female
|
4 Eyes
n=20 Eyes
|
5 Eyes
n=20 Eyes
|
9 Eyes
n=40 Eyes
|
|
Sex/Gender, Customized
Gender : Male
|
16 Eyes
n=20 Eyes
|
15 Eyes
n=20 Eyes
|
31 Eyes
n=40 Eyes
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Number of Right Eyes Enrolled
|
7 Eyes
n=20 Eyes
|
11 Eyes
n=20 Eyes
|
18 Eyes
n=40 Eyes
|
|
Glycated Hemoglobin
|
8.8 Percentage
n=20 Eyes
|
8.0 Percentage
n=20 Eyes
|
8.4 Percentage
n=40 Eyes
|
|
Diabetes Mellitus Diagnosis Year
|
2002 year
n=20 Eyes
|
2001 year
n=20 Eyes
|
2001 year
n=40 Eyes
|
|
Diabetic Macular Edema Diagnosis Year
|
2012 year
n=20 Eyes
|
2012 year
n=20 Eyes
|
2012 year
n=40 Eyes
|
|
Early Treatment Diabetic Retinopathy Study Best-Corrected Visual Acuity
|
59.1 letters
n=20 Eyes
|
60.1 letters
n=20 Eyes
|
59.6 letters
n=40 Eyes
|
|
Central Retinal Thickness
|
571 microns
n=20 Eyes
|
488 microns
n=20 Eyes
|
530 microns
n=40 Eyes
|
PRIMARY outcome
Timeframe: 36 MonthsPopulation: All participants were included in analysis. Among participants who failed to complete the study, the last observation was carried forward for analysis at Month 36.
Assess the number of ranibizumab injections in the ranibizumab and targeted panretinal photocoagulation (PRP) with ranibizumab cohorts through Month 36.
Outcome measures
| Measure |
0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Total Number of Ranibizumab Injections in Each of the Two Cohorts in a 36 Month Period
|
24.4 injections
Interval 10.0 to 34.0
|
27.1 injections
Interval 12.0 to 36.0
|
PRIMARY outcome
Timeframe: 36 MonthsPopulation: All participants were included in analysis. Among participants who failed to complete the study, the last observation was carried forward for analysis at Month 36.
Evaluate the mean change over time in ETDRS BCVA in the ranibizumab and targeted PRP with ranibizumab cohorts through Month 36.
Outcome measures
| Measure |
0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Mean Change Over Time in Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS BCVA) Through Month 36
|
13.9 letters
Standard Deviation 10.2
|
8.2 letters
Standard Deviation 16.1
|
PRIMARY outcome
Timeframe: 36 MonthsIncidence and severity of ocular and non-ocular adverse events (AE's) in the monotherapy and combination cohorts through Month 36.
Outcome measures
| Measure |
0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Incidence and Severity of Ocular and Non-ocular Adverse Events (AE's) Through Month 36.
Participants Experiencing Serious Ocular AE
|
2 Participants
|
1 Participants
|
|
Incidence and Severity of Ocular and Non-ocular Adverse Events (AE's) Through Month 36.
Participants Experiencing Serious Systemic AE
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Month 12, 24, and 36Population: All participants were included in analysis. Due to participant attrition and missed visits, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.
Percentage of patients in the ranibizumab and targeted PRP with ranibizumab cohorts who experience a loss of 15 or more letters from Baseline to Month 12, 24, and 36 in ETDRS BCVA.
Outcome measures
| Measure |
0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12, 24, and 36 in ETDRS BCVA.
24 Months
|
0 Participants
|
1 Participants
|
|
Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12, 24, and 36 in ETDRS BCVA.
36 Months
|
0 Participants
|
1 Participants
|
|
Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12, 24, and 36 in ETDRS BCVA.
12 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 12, 24, and 36Population: All participants were included in analysis. Due to participant attrition and missed visits, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.
Determine percentage of patients who experience a gain of 15 or more letters from Baseline to Month 12, 24, and 36 in ETDRS BCVA in the ranibizumab and targeted PRP with ranibizumab cohorts.
Outcome measures
| Measure |
0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Determine Percentage of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12, 24, and 36 in ETDRS BCVA
Month 12
|
10 Participants
|
5 Participants
|
|
Determine Percentage of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12, 24, and 36 in ETDRS BCVA
Month 24
|
10 Participants
|
6 Participants
|
|
Determine Percentage of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12, 24, and 36 in ETDRS BCVA
Month 36
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Month 12, 24, and 36Population: All participants were included in analysis. Due to participant attrition and missed visits, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.
Evaluate mean change in central retinal thickness in the ranibizumab and targeted PRP with ranibizumab cohorts over time through Month 12, 24, and 36 as assessed by high resolution OCT's.
Outcome measures
| Measure |
0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=20 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Evaluate Mean Change in Central Retinal Thickness Over Time Through Month 12, 24, and 36 as Assessed by High Resolution OCT's.
Month 12
|
-301 microns
Standard Deviation 255
|
-161 microns
Standard Deviation 188
|
|
Evaluate Mean Change in Central Retinal Thickness Over Time Through Month 12, 24, and 36 as Assessed by High Resolution OCT's.
Month 24
|
-296 microns
Standard Deviation 238
|
-169 microns
Standard Deviation 172
|
|
Evaluate Mean Change in Central Retinal Thickness Over Time Through Month 12, 24, and 36 as Assessed by High Resolution OCT's.
Month 36
|
-302 microns
Standard Deviation 246
|
-152 microns
Standard Deviation 149
|
SECONDARY outcome
Timeframe: Month 36Population: All participants were included in analysis. Due to participant attrition and missed visits, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.
Percentage of patients with persistent macular edema post-intravitreal injection in the ranibizumab and targeted PRP with ranibizumab cohorts.
Outcome measures
| Measure |
0.3 mg Ranibizumab
n=17 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=18 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Patients With Persistent Macular Edema Post-intravitreal Injection.
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: Participants that had poor fix (resulting in inaccurate results), missing baseline results, or missing Month 36 results were excluded.
Mean change in peripheral visual field as measured by Goldmann visual field at screen and Month 36 in the ranibizumab and targeted PRP with ranibizumab cohorts.
Outcome measures
| Measure |
0.3 mg Ranibizumab
n=9 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=8 Participants
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Mean Change in Peripheral Visual Field as Measured by Goldmann Visual Field at Screen and Month and 36.
|
-215 degrees squared
Standard Deviation 1957
|
-1723 degrees squared
Standard Deviation 3532
|
Adverse Events
0.3 mg Ranibizumab
Serious events: 9 serious events
Other events: 12 other events
Deaths: 0 deaths
Targeted PRP With 0.3 mg Ranibizumab
Serious events: 10 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.3 mg Ranibizumab
n=20 participants at risk
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=20 participants at risk
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Eye disorders
Neovascular glaucoma
|
10.0%
2/20 • Number of events 2 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
0.00%
0/20 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Vitreous hemorrhage with acute vision loss
|
0.00%
0/20 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Immune system disorders
Sepsis
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Cardiac disorders
Systolic heart failure
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Cardiac disorders
Atrial flutter
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/20 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.0%
2/20 • Number of events 2 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitits
|
15.0%
3/20 • Number of events 3 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
10.0%
2/20 • Number of events 2 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Renal and urinary disorders
Worsening renal failure
|
15.0%
3/20 • Number of events 3 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
20.0%
4/20 • Number of events 4 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
Other adverse events
| Measure |
0.3 mg Ranibizumab
n=20 participants at risk
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
|
Targeted PRP With 0.3 mg Ranibizumab
n=20 participants at risk
Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan-retinal photocoagulation (PRP) based on ultra wide 200º field angiography (see Appendix C). After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
|
|---|---|---|
|
Eye disorders
Vitreous hemorrhage
|
10.0%
2/20 • Number of events 2 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
10.0%
2/20 • Number of events 2 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Neovascularization elsewhere
|
20.0%
4/20 • Number of events 4 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
0.00%
0/20 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Neovascularization of the disc
|
10.0%
2/20 • Number of events 2 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
0.00%
0/20 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Neovascularization of the iris
|
5.0%
1/20 • Number of events 2 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
0.00%
0/20 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Worsening glaucoma
|
15.0%
3/20 • Number of events 3 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
0.00%
0/20 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Worsening cataract
|
15.0%
3/20 • Number of events 3 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
30.0%
6/20 • Number of events 6 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Posterior vitreous detachment
|
20.0%
4/20 • Number of events 4 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
25.0%
5/20 • Number of events 5 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Epiretinal membrane
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
15.0%
3/20 • Number of events 3 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Hyphema
|
10.0%
2/20 • Number of events 2 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
0.00%
0/20 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
|
Eye disorders
Dilated pupil
|
0.00%
0/20 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
5.0%
1/20 • Number of events 1 • 3 years (entire study period)
Adverse events were assessed at every study visit during the 3-year trial
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place