Conditions: Visual Impairment Macular Edema Branch Retinal Vein Occlusion
Keywords: Visual impairment macular edema branch retinal vein occlusion Dexamethasone implant Ranibizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 244
Healthy volunteers: no

Brief summary:
This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.

Detailed description:

Arms:
arm 1: Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally arm 2: Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months

Interventions: intervention 1: Ranibizumab intervention 2: Dexamethasone Implant intervention 3: Sham injection
Intervention descriptions: intervention 1: Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split intervention 2: Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only. intervention 3: Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration

Protocol document: