NCT01599650

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

A 24-month, Phase IIIb, Open-label, Randomized, Active Controlled, 3-arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy or With Adjunctive Laser Photocoagulation in Comparison to Laser Photocoagulation in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Branch Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Ranibizumab
PROCEDURE	Laser	laser photocoagulation

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-05-16
• Last updated: 2016-11-10
• Results posted: 2016-11-10

Locations

82 sites across 17 countries: Australia, Canada, Czechia, Denmark, France, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom