Conditions: Diabetic Macular Edema
Keywords: DME Diabetic macula edema RETAIN ranibizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 373
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.

Detailed description:

Arms:
arm 1: On Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections. Laser therapy was applied at Day 1. It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months. Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection. arm 2: Patients received ranibizumab intravitreal injection therapy only. arm 3: Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.

Protocol document: