CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 252 enrolled
Drug / intervention
Ranibizumab 0.5 mg +1 moredrug
Likely dose
Ranibizumab 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01976312
NCT01976312Phase 3Completed
CompareCT.gov

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]

Novartis Pharmaceuticals·interventional·Posted Nov 5, 2013·Updated May 30, 2017

In Brief

A Phase 3 clinical trial evaluating Sham injection and Ranibizumab 0.5 mg for Central Retinal Vein Occlusion. Completed, enrolled 252 participants across 34 sites in 7 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCentral Retinal Vein Occlusion
CountriesChina, Hong Kong, India, Indonesia, Philippines, Taiwan, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2013
Enrollment StartNov 12, 2013
Primary CompletionMar 14, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.7 years ago

Interventions

Sham injectionother

Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.

Ranibizumab 0.5 mgdrug

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