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NCT01277302 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion
A Phase 4 study of Macular Edema, sponsored by Genentech.
- Completed
- Registry status
- Phase 4
- Development phase
- 202
- Enrollment target
- 20
- Study locations
NCT01277302: Completed Phase 4 study of Macular Edema, sponsored by Genentech.
NCT01277302 is a Phase 4 study of Macular Edema that has completed, run by Genentech. The registered enrollment target is 202 participants, above the 165-participant average among 14 other Macular Edema trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01277302, a Phase 4 study of Macular Edema, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 202 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a Phase IV multicenter, randomized, open-label study, with masking of the vision examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).
Primary Outcome
BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by ti
Conditions Studied
Interventions
- DRUG Ranibizumab
Study Locations (20)
California
- - Beverly Hills
- - Chico
- - Mountain View
- - Oakland
- - San Francisco
- - Santa Ana
- - Santa Barbara
- - Torrance
Florida
- - Altamonte Springs
- - Boynton Beach
- - Lakeland
Arizona
- - Phoenix
- - Tucson
Colorado
- - Colorado Springs
- - Golden
Maryland
- - Baltimore
- - Hagerstown
Connecticut
- - New London
Georgia
- - Augusta
Illinois
- - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-10 |
| Phase | Phase 4 |
What the finished NCT01277302 record still lists
NCT01277302 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, above the 165-participant average among 14 other Macular Edema trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which Ranibizumab is the first listed.
NCT01277302 names 20 study sites across 8 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01277302 about?
NCT01277302 is a clinical study titled "A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion". This was a Phase IV multicenter, randomized, open-label study, with masking of the vision examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).
What is the current status of trial NCT01277302?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 202 participants. The study started on 2011-02. Estimated completion is 2012-10.
What conditions does trial NCT01277302 study?
This clinical trial studies the following conditions: Macular Edema.
What interventions are being tested in trial NCT01277302?
The interventions under investigation include: Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT01277302?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01277302 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Macular Edema
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Where NCT01277302's enrollment target sits among peer trials
202 3rd of 14 higher than 12 of 14 other Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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