Conditions: Diabetic Macular Edema
Keywords: DME Diabetic macula edema ranibizumab REVEAL
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 396
Healthy volunteers: no

Brief summary:
This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).

Detailed description:

Arms:
arm 1: Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser. arm 2: Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser. arm 3: Active laser treatment plus sham intravitreal injections.

Interventions: intervention 1: Ranibizumab intervention 2: Laser photocoagulation intervention 3: Sham ranibizumab intervention 4: Sham laser photocoagulation
Intervention descriptions: intervention 1: Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed. intervention 2: Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment. intervention 3: Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed. intervention 4: Sham laser treatment administered at day 1.

Protocol document: