Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ranibizumab

Criteria

Inclusion Criteria:

• Patients diagnosed with visual impairment due to macular edema following BRVO

• Diagnosis of BRVO at maximum 6 months prior to Screening

• BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Exclusion Criteria:

• Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs

• Central retinal thickness (CRT) < 250 µm in the study eye

• Prior episode of RVO in the study eye

• Active formation of new vessels in the study eye

• Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline

• IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment

• Improvement of > 10 letters on BCVA between Screening and Baseline

Other protocol-defined inclusion/exclusion criteria may apply