At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 363 enrolled
Drug / intervention
dexamethasone Intravitreal Implant +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.
Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
In Brief
A Phase 2 clinical trial evaluating dexamethasone Intravitreal Implant and ranibizumab for Macular Edema. Completed, enrolled 363 participants across 13 sites in 12 countries.
Detailed Summary
This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Edema
CountriesBelgium, Denmark, France, Germany, Israel, Italy, Netherlands, Portugal, South Africa, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartMar 2012
Primary CompletionFeb 2014
TodayJul 2026
First PostedDec 15, 2011
Enrollment StartMar 9, 2012
Primary CompletionFeb 13, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.5 years ago
Interventions
dexamethasone Intravitreal Implantdrug
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
ranibizumabdrug
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.