At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 83 enrolled
Drug / intervention
RFB002 +1 moredrug
Likely dose
RFB002 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.
A Randomized, Open Label, Multicenter, Laser-controlled Phase II Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) vs. Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
In Brief
A Phase 2 clinical trial evaluating RFB002 and Laser photocoagulation for Diabetic Macular Edema and Visual Impairment. Completed, enrolled 83 participants across 17 sites.
Detailed Summary
This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema, Visual Impairment
CountriesSpain
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartNov 2009
Primary CompletionAug 2012
TodayJul 2026
First PostedMay 13, 2009
Enrollment StartNov 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.1 years ago
Interventions
RFB002drug
0.5 mg
Laser photocoagulationprocedure