CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 307 enrolled
Drug / intervention
dexamethasone intravitreal implant +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.

Search/NCT01427751
NCT01427751Phase 4Completed
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Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion

Allergan·interventional·Posted Sep 2, 2011·Updated Apr 18, 2019

In Brief

A Phase 4 clinical trial evaluating dexamethasone intravitreal implant and ranibizumab for Retinal Vein Occlusion and Macular Edema. Completed, enrolled 307 participants across 6 sites in 6 countries.

Detailed Summary

This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinal Vein Occlusion, Macular Edema
CountriesFrance, Germany, Israel, Italy, Spain, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2011
Enrollment StartOct 11, 2011
Primary CompletionNov 4, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.8 years ago

Interventions

dexamethasone intravitreal implantdrug

Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.

ranibizumabbiological

Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.