At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 181 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 Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema
In Brief
A Phase 3 clinical trial evaluating Sham control and Ranibizumab for Macular Edema (ME). Completed, enrolled 181 participants across 61 sites in 19 countries.
Detailed Summary
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Edema (ME)
CountriesAustralia, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Latvia, Netherlands, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartOct 2013
Primary CompletionSep 2015
TodayJul 2026
First PostedMay 3, 2013
Enrollment StartOct 1, 2013
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.2 years ago
Interventions
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.
Ranibizumabdrug
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.