Trial Outcomes & Findings for Study of the Efficacy and Tolerability of Intravitreal Injections of Ranibizumab Compared to Intravitreal Injections of Ranibizumab Combined With Targeted Retinal Photocoagulation to Treat Radiation Retinopathy. (NCT NCT02222610)
NCT ID: NCT02222610
Last Updated: 2021-03-25
Results Overview
Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) utilizes the ETDRS visual acuity chart to measure vision in clinical trials. Standard unit of measure is the number of letters subjects are able to read on the chart.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
104 weeks
Results posted on
2021-03-25
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
Cohort A
Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.
Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
0.5 mg ranibizumab
|
Cohort B
Subject's receive monthly treatment of intravitreal (IVT) 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Cohort C
Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
|---|---|---|---|
|
Baseline to W48
STARTED
|
8 8
|
16 16
|
16 16
|
|
Baseline to W48
COMPLETED
|
8 8
|
14 14
|
15 15
|
|
Baseline to W48
NOT COMPLETED
|
0 0
|
2 2
|
1 1
|
|
Baseline to W104
STARTED
|
8 8
|
16 16
|
16 16
|
|
Baseline to W104
COMPLETED
|
8 8
|
11 11
|
10 10
|
|
Baseline to W104
NOT COMPLETED
|
0 0
|
5 5
|
6 6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Efficacy and Tolerability of Intravitreal Injections of Ranibizumab Compared to Intravitreal Injections of Ranibizumab Combined With Targeted Retinal Photocoagulation to Treat Radiation Retinopathy.
Baseline characteristics by cohort
| Measure |
Cohort A
n=8 Eyes
Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.
Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
0.5 mg ranibizumab
|
Cohort B
n=16 Eyes
Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Cohort C
n=16 Eyes
Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Total
n=40 Eyes
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.125 years
n=14 Eyes
|
54.813 years
n=23 Eyes
|
60.438 years
n=50 Eyes
|
57 years
n=50 Eyes
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
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 (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Best-Corrected Visual Acuity
|
60.875 letters
n=5 Participants
|
55.813 letters
n=7 Participants
|
55.375 letters
n=5 Participants
|
56.7 letters
n=4 Participants
|
PRIMARY outcome
Timeframe: 104 weeksPopulation: Subjects analyzed only include those that completed the W104 visit.
Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) utilizes the ETDRS visual acuity chart to measure vision in clinical trials. Standard unit of measure is the number of letters subjects are able to read on the chart.
Outcome measures
| Measure |
Cohort A
n=8 Participants
Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.
Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
0.5 mg ranibizumab
|
Cohort B
n=11 Participants
Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Cohort C
n=10 Participants
Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
|---|---|---|---|
|
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0.
|
-1.9 letters
Standard Deviation 7.4
|
-3.9 letters
Standard Deviation 16.5
|
1.3 letters
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 104 weeksOutcome measures
| Measure |
Cohort A
n=8 Participants
Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.
Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
0.5 mg ranibizumab
|
Cohort B
n=16 Participants
Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Cohort C
n=16 Participants
Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
|---|---|---|---|
|
The Mean Number of Intravitreal Injections Required Per Subject Per Cohort.
|
22.2 injections
Interval 19.0 to 25.0
|
18.5 injections
Interval 11.0 to 25.0
|
16.1 injections
Interval 6.0 to 26.0
|
SECONDARY outcome
Timeframe: 104 weeksOutcome measures
| Measure |
Cohort A
n=8 Participants
Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.
Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
0.5 mg ranibizumab
|
Cohort B
n=16 Participants
Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Cohort C
n=16 Participants
Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
|---|---|---|---|
|
Percentage of Subjects With Retinal Hemorrhage at 104 Weeks.
|
1 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 104 weeksOutcome measures
| Measure |
Cohort A
n=8 Participants
Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.
Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
0.5 mg ranibizumab
|
Cohort B
n=16 Participants
Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Cohort C
n=16 Participants
Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
|---|---|---|---|
|
Percentage of Subjects With Intraretinal Exudates on Fundus Examination at Week 104.
|
1 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 104 weeksSpectral-domain optical coherence tomography (SD-OCT) is a common imaging modality used to visualize the layers of the macula. Central mean thickness (CMT) is the length in microns from the internal limiting membrane to Bruch's membrane.
Outcome measures
| Measure |
Cohort A
n=8 Participants
Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.
Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
0.5 mg ranibizumab
|
Cohort B
n=16 Participants
Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Cohort C
n=16 Participants
Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
|---|---|---|---|
|
Mean Change in Central Mean Thickness According to Spectral-domain Optical Coherence Tomography at Week 104 Compared to Baseline.
|
-8.5 micrometers
Standard Deviation 216.7
|
-87 micrometers
Standard Deviation 174.8
|
-74.6 micrometers
Standard Deviation 176.7
|
Adverse Events
Cohort A
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort C
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort A
n=8 participants at risk
Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.
Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
0.5 mg ranibizumab
|
Cohort B
n=16 participants at risk
Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Cohort C
n=16 participants at risk
Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
|---|---|---|---|
|
Cardiac disorders
Acute Chronic Diastolic Heart Failure
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Renal and urinary disorders
Acute Chronic Renal Failure
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Broken Wrist
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Eye disorders
Central Retinal Artery Occlusion
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Cardiac disorders
Chronic Atrial Fibrillation
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Eye disorders
Recurrence of Choroidal Melanoma
|
0.00%
0/8 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Eye disorders
Metastatic Uveal Melanom
|
12.5%
1/8 • Number of events 1 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
|
Endocrine disorders
Pancreatitis
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Cardiac disorders
Worsening of Hypertension
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
12.5%
2/16 • Number of events 2 • Baseline through 104 weeks
|
Other adverse events
| Measure |
Cohort A
n=8 participants at risk
Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks.
Starting at week 52, subject's will enter a treat \& extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks \& develops recurrent disease activity, the eye is treated \& the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again.
0.5 mg ranibizumab
|
Cohort B
n=16 participants at risk
Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
Cohort C
n=16 participants at risk
Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks \& 24 weeks \& will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia.
Starting at week 52, subject's will enter a treat \& extend regime as described in cohort A.
0.5 mg ranibizumab
Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia
|
|---|---|---|---|
|
Eye disorders
Corneal Abrasion
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Eye disorders
Dry Eyes
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Eye disorders
Increased Cup-to-Disc Rratio
|
0.00%
0/8 • Baseline through 104 weeks
|
12.5%
2/16 • Number of events 2 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
|
Eye disorders
Ocular Irritation
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Eye disorders
Ocular Pain
|
0.00%
0/8 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 2 • Baseline through 104 weeks
|
|
Eye disorders
Posterior Capsular Opacification
|
0.00%
0/8 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
12.5%
2/16 • Number of events 3 • Baseline through 104 weeks
|
|
Eye disorders
Posterior Vitreous Detachment
|
12.5%
1/8 • Number of events 1 • Baseline through 104 weeks
|
18.8%
3/16 • Number of events 3 • Baseline through 104 weeks
|
6.2%
1/16 • Number of events 1 • Baseline through 104 weeks
|
|
Eye disorders
Subconjunctival Hemorrhage
|
12.5%
1/8 • Number of events 1 • Baseline through 104 weeks
|
0.00%
0/16 • Baseline through 104 weeks
|
12.5%
2/16 • Number of events 2 • Baseline through 104 weeks
|
|
Eye disorders
Worsening of Cataracts
|
25.0%
2/8 • Number of events 2 • Baseline through 104 weeks
|
31.2%
5/16 • Number of events 6 • Baseline through 104 weeks
|
18.8%
3/16 • Number of events 3 • Baseline through 104 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place