NCT01976312

Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)

A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Central Retinal Vein Occlusion (CRVO) [Camellia]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO

Conditions

• Central Retinal Vein Occlusion

Interventions

Type	Name	Description
OTHER	Sham injection	Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.
DRUG	Ranibizumab 0.5 mg	Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only

Timeline

• Start date: 2013-11-12
• Primary completion: 2016-03-14
• Completion: 2016-03-14
• First posted: 2013-11-05
• Last updated: 2017-05-30
• Results posted: 2017-04-24

Locations

34 sites across 7 countries: China, Hong Kong, India, Indonesia, Philippines, Taiwan, Vietnam