Conditions: Visual Impairment Due to Diabetic Macular Edema
Keywords: Diabetic macular edema DME Proliferative diabetic retinopathy PDR ranibizumab laser
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: no

Brief summary:
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.

Detailed description:

Arms:
arm 1: Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. arm 2: Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Interventions: intervention 1: Active laser photocoagulation intervention 2: Sham injections intervention 3: Ranibizumab 0.5 mg
Intervention descriptions: intervention 1: Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. intervention 2: Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. intervention 3: Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Protocol document: