Conditions: Diabetic Macular Edema Visual Impairment
Keywords: Diabetic Macular Edema Ranibizumab Laser Treatment Visual impairment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved. arm 2: At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.

Interventions: intervention 1: RFB002 intervention 2: Laser photocoagulation
Intervention descriptions: intervention 1: 0.5 mg intervention 2: None

Protocol document: