At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 183 enrolled
Drug / intervention
Ranibizumab +1 moredrug
Likely dose
Ranibizumab 0.5mgfrom 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.
A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.
In Brief
A Phase 3 clinical trial evaluating Ranibizumab and Sham control for Choroidal Neovascularization (CNV). Completed, enrolled 183 participants across 59 sites in 21 countries.
Detailed Summary
This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChoroidal Neovascularization (CNV)
CountriesAustralia, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Peru, Poland, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye)
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartSep 2013
Primary CompletionNov 2015
TodayJul 2026
First PostedApr 25, 2013
Enrollment StartSep 1, 2013
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.2 years ago
Interventions
Ranibizumabdrug
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Sham controlother
The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.