Conditions: Diabetic Macular Edema Visual Impairment
Keywords: DME macular edema vision impairment Chinese diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 384
Healthy volunteers: no

Brief summary:
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)

Detailed description:
The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.

Arms:
arm 1: 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser arm 2: Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections

Interventions: intervention 1: Ranibizumab (RFB002) intervention 2: Laser intervention 3: Sham injection intervention 4: Sham laser
Intervention descriptions: intervention 1: Ranibizumab 0.5 mg/0.05 mL for intravitreal injection intervention 2: Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines intervention 3: Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle intervention 4: Imitation of an active laser

Protocol document: