Trial Outcomes & Findings for Widefield Angiography Guided Targeted-retinal Photocoagulation Combined With Anti VEgf Intravitreal Injections for the Treatment of Ischemic Central Retinal Vein Occlusion, Hemi Retinal Vein Occlusion, and Branch Retinal Vein Occlusion (NCT NCT01710839)
NCT ID: NCT01710839
Last Updated: 2017-09-08
Results Overview
Assess the number of intravitreal injections over 12 months.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
12 months
Results posted on
2017-09-08
Participant Flow
Participant milestones
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
6
|
|
Overall Study
COMPLETED
|
23
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Widefield Angiography Guided Targeted-retinal Photocoagulation Combined With Anti VEgf Intravitreal Injections for the Treatment of Ischemic Central Retinal Vein Occlusion, Hemi Retinal Vein Occlusion, and Branch Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
n=24 Participants
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
n=6 Participants
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
n=5 Participants
|
63.8 years
n=7 Participants
|
64.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
RVO Subtype
CRVO
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
RVO Subtype
BRVO
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
RVO Subtype
HRVO
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Prior Anti-VEGF Injections
|
10.2 injections
n=5 Participants
|
10.0 injections
n=7 Participants
|
10.1 injections
n=5 Participants
|
|
ETDRS BCVA Letters
|
51.7 ETDRS BCVA Letters
n=5 Participants
|
55.3 ETDRS BCVA Letters
n=7 Participants
|
52.4 ETDRS BCVA Letters
n=5 Participants
|
|
Central Retinal Thickness
|
525 micrometers
n=5 Participants
|
471 micrometers
n=7 Participants
|
514 micrometers
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAssess the number of intravitreal injections over 12 months.
Outcome measures
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
n=24 Participants
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
n=6 Participants
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
|---|---|---|
|
Total Number of Intravitreal Injections Over a 12 Month Period
|
8.7 injections
Interval 5.0 to 12.0
|
9.5 injections
Interval 7.0 to 12.0
|
PRIMARY outcome
Timeframe: 12 month periodPopulation: 1 patient withdrew from the study before month 12
Evaluate the mean change from baseline in ETDRS best-corrected visual acuity at 12 months. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning.
Outcome measures
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
n=23 Participants
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
n=6 Participants
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
|---|---|---|
|
Visual Acuity
|
14.9 ETDRS BCVA Letters
Standard Error 3.4
|
10.7 ETDRS BCVA Letters
Standard Error 4.4
|
SECONDARY outcome
Timeframe: 12 month periodPopulation: Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.
Quantify change in area of perfused and ischemic retina.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.
Assess change in foveal avascular zone area and largest diameter, measured during the early phase of the angiogram
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsIncidence and severity of adverse events (ocular and non-ocular).
Outcome measures
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
n=24 Participants
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
n=6 Participants
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
|---|---|---|
|
Adverse Events
Notable Ocular Events
|
17 Participants
|
2 Participants
|
|
Adverse Events
Serious Non-Ocular Events
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPercent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.
Outcome measures
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
n=24 Participants
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
n=6 Participants
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
|---|---|---|
|
Neovascularization of the Iris, Optic Nerve and Elsewhere
|
8.33 percentage of patients
|
0 percentage of patients
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 1 patient withdrew from the study before month 12
Mean change in Central Foveal Volume on High Resolution OCT.
Outcome measures
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
n=23 Participants
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
n=6 Participants
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
|---|---|---|
|
Central Foveal Outcome
|
-0.15 cubic millimeters
Standard Deviation .21
|
-0.15 cubic millimeters
Standard Deviation .20
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.
VEGF, other cytokines and ranibizumab levels in aqueous and serum samples at randomization and at the exit or early termination visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 and 12 MonthsPopulation: Patients who completed GVF testing at baseline, M6, and M12 with adequate fixation and cooperation during testing were included in GVF analyses (n=14)
Goldman Visual Field changes at 6 and 12 months from baseline. Goldmann perimetry is a method used to map a patient's field of vision (central and peripheral). Changes will be assessed by manual digital quantification of GVF plots.
Outcome measures
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
n=11 Participants
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
n=3 Participants
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
|---|---|---|
|
Visual Field
Month 6
|
-1269 square degrees
Standard Error 180
|
102 square degrees
Standard Error 423
|
|
Visual Field
Month 12
|
-1628 square degrees
Standard Error 353
|
-1875 square degrees
Standard Error 326
|
Adverse Events
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Ranibizumab 0.5mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
n=24 participants at risk
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
n=6 participants at risk
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
|---|---|---|
|
Vascular disorders
Hemorrhoids with rectal bleeding
|
4.2%
1/24 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Cardiac disorders
Bradycardia
|
4.2%
1/24 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
Other adverse events
| Measure |
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab
n=24 participants at risk
Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
0.5mg Ranibizumab: intravitreal injections
Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography
|
Ranibizumab 0.5mg
n=6 participants at risk
Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
0.5mg Ranibizumab: intravitreal injections
|
|---|---|---|
|
Eye disorders
Glaucoma suspect
|
4.2%
1/24 • Number of events 1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Eye disorders
Cataract progression
|
12.5%
3/24 • Number of events 3 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Eye disorders
Visual distortion
|
33.3%
8/24 • Number of events 8 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Posterior vitreous detachment
|
12.5%
3/24 • Number of events 3 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Vitreous hemorrhage
|
4.2%
1/24 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Epiretinal membrane
|
4.2%
1/24 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
Additional Information
Charles C Wykoff, PhD, MD
Retina Consultants of Houston
Phone: 713-524-3434
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place