Who is the sponsor?
Who are the patients?
Male or female patients over the age of eighteen with branch retinal vein occlusion (BRVO) or hemi-retinal vein occlusion (HRVO). The participating doctor will evaluate the patient to determine his/her eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long is trial?
Participants will be monitored for two years.
When did the study start at our site?
What is the enrollment goal for the sponsor?
300 patients between 70 sites
Is the enrollment still open?
The study is ongoing but enrollment is closed.
What is this study investigating?
This is a Phase III, multi-center, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab (Lucentis) injection compared with sham in subjects with macular edema secondary to branch- or hemi- retinal vein occlusion with the following objectives: To evaluate the efficacy of intravitreal injections of ranibizumab administered monthly for six months in the improvement of visual acuity as measured by the mean change in best corrected visual acuity (BCVA), visual acuity outcomes other than BCVA, anatomic changes, and patient reported visual function outcomes at 6 months compared to baseline To evaluate the safety and tolerability of intravitreal injections of ranibizumab administered monthly for 6 months, followed by a 6 month observation period with protocol-specified retreatment criteria. To evaluate the pharmacokinetics of ranibizumab in subjects with BRVO.
How is the treatment administered?
Ranibizumab is administered as an injection into the eye. A powerful beam of light is focused onto the retina using specialized ophthalmic equipment and lenses.