NCT01396057

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

A 6-month Multicenter, Randomized, Double-masked Phase IIIb-study Comparing the Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Branch Retinal Vein Occlusion (BRVO)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Visual Impairment
• Macular Edema
• Branch Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Ranibizumab	Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split
OTHER	Dexamethasone Implant	Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.
OTHER	Sham injection	Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-07-18
• Last updated: 2014-08-07
• Results posted: 2014-07-16

Locations

66 sites across 5 countries: Czechia, Germany, Hungary, Poland, United Kingdom