Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Written informed consent must be obtained before any study assessment is performed

• Diagnosis of visual impairment exclusively due to ME secondary to BRVO

• BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)

Exclusion Criteria:

• Pregnant or nursing (lactating) women

• Stroke or myocardial infarction less than 3 months before Screening

• Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.

• Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye

• Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye

• Neovascularization of the iris or neovascular glaucoma in the study eye

• Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline

• Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye

• Focal or grid laser photocoagulation within 4 months before Baseline in the study eye

• Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye

• Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye