Trial Outcomes & Findings for Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2) (NCT NCT01225146)
NCT ID: NCT01225146
Last Updated: 2017-08-14
Results Overview
Mean change from baseline in ETDRS NCVA.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
12 months.
Results posted on
2017-08-14
Participant Flow
Participant milestones
| Measure |
Treatment Experienced (Cohort 1
Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
Treatment Naive (Cohort 2)
Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Treatment Experienced (Cohort 1
Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
Treatment Naive (Cohort 2)
Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
|---|---|---|
|
Overall Study
Sponsor discontinued making 2mg drug
|
0
|
2
|
Baseline Characteristics
Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
Cohort 2
n=2 Participants
Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
64.7 years
n=99 Participants
|
56.5 years
n=107 Participants
|
62.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 months.Population: Patients in cohort 2 did not complete the study.
Mean change from baseline in ETDRS NCVA.
Outcome measures
| Measure |
Treatment Experienced (Cohort 1
n=6 Participants
Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
Treatment Naive (Cohort 2)
Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
|---|---|---|
|
Mean Change in logMAR
|
0.91 logMAR
Interval 0.4 to 1.42
|
—
|
SECONDARY outcome
Timeframe: 12 monthsIncidence and severity of adverse events (ocular and non-ocular) from baseline through 12 months will be evaluated.
Outcome measures
| Measure |
Treatment Experienced (Cohort 1
n=6 Participants
Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
Treatment Naive (Cohort 2)
n=2 Participants
Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
|---|---|---|
|
Incidence and Severity of Adverse Events (Ocular and Non-ocular).
Ocular Events
|
1 incidents
|
0 incidents
|
|
Incidence and Severity of Adverse Events (Ocular and Non-ocular).
Non-Ocular Events
|
0 incidents
|
0 incidents
|
|
Incidence and Severity of Adverse Events (Ocular and Non-ocular).
Serious Ocular Events
|
0 incidents
|
0 incidents
|
|
Incidence and Severity of Adverse Events (Ocular and Non-ocular).
Serious Non-Ocular Events
|
0 incidents
|
0 incidents
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients in cohort 2 did not complete the study.
Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.
Outcome measures
| Measure |
Treatment Experienced (Cohort 1
n=6 Participants
Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
Treatment Naive (Cohort 2)
Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
|---|---|---|
|
Neovascularization Development
|
0 Percentage of patients
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients in cohort 2 did not complete the study.
Mean change in Central Foveal Volume on High Resolution OCT
Outcome measures
| Measure |
Treatment Experienced (Cohort 1
n=6 Participants
Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
Treatment Naive (Cohort 2)
Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
|---|---|---|
|
Mean Change in Central Foveal Volume
|
0.03 mm^3
Interval -0.03 to 0.24
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246)
Changes, by disc areas, of capillary non-perfusion in the periphery (evaluated by wide-field fluorescein angiography) at 3, 6, 9 and 12 months from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246)
Goldman Visual Field changes at 6 and 12 months from baseline
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=6 participants at risk
Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).
Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
Cohort 2
n=2 participants at risk
Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
ranibizumab: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
|
|---|---|---|
|
Eye disorders
Increased cup to disk ratio
|
16.7%
1/6 • 1 year
Ocular and non-ocular adverse events were documented.
|
0.00%
0/2 • 1 year
Ocular and non-ocular adverse events were documented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place