Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema Diabetic Retinopathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 466
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.

Detailed description:

Arms:
arm 1: Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks. arm 2: Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks. arm 3: Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.

Interventions: intervention 1: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) intervention 2: Macular Laser Photocoagulation
Intervention descriptions: intervention 1: None intervention 2: Laser therapy

Protocol document: