At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) as Adjunctive and Mono-therapy in Patients With Visual Impairment Due to Diabetic Macular Edema
In Brief
A Phase 3 clinical trial evaluating Ranibizumab, Laser, and 2 other interventions for Diabetic Macular Edema. Completed, enrolled 345 participants across 13 sites in 13 countries.
Detailed Summary
CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with visual impairment due to diabetic macular edema. CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12 month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as symptomatic treatment for visual impairment due to diabetic macular edema.
Study Details
Timeline
Interventions
0.5 mg ranibizumab administered by intravitreal injection.
Laser photocoagulation treatment
Sham to laser procedure.
Sham to ranibizumab administered as an intravitreal injection.