At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 243 enrolled
Drug / intervention
Ranibizumab +1 moredrug
Likely dose
Not stated in 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 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 Central Retinal Vein Occlusion (CRVO)
In Brief
A Phase 3 clinical trial evaluating Ranibizumab and Dexamethasone implant and sham injections for Visual Impairment and 2 related conditions. Completed, enrolled 243 participants across 64 sites in 4 countries.
Detailed Summary
This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Hungary, Poland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartAug 2011
Primary CompletionJan 2014
TodayJul 2026
First PostedJul 18, 2011
Enrollment StartAug 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.0 years ago
Interventions
Ranibizumabdrug
Dexamethasone implant and sham injectionsdrug