Conditions: Retinal Vein Occlusion
Keywords: Macular Degeneration Macular Edema Retinal Vein Occlusion Choroidal Neovascularization Signs and Symptoms Retinal Degeneration Retinal Diseases Eye Diseases Venous Thrombosis Sensation Disorders Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Vision, Low Signs Vision Disorders
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 175
Healthy volunteers: no

Brief summary:
The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).

Detailed description:

Arms:
arm 1: The PRN injection scheme applied in the core study will also be followed during this extension study:

Patients should be monitored monthly (starting at V1E) for VA and treatment is to be resumed when monitoring indicates loss of VA due to disease activity. Monthly injections should then be administered until stable VA is reached again for 3 consecutive monthly assessments (implying a minimum of 2 injections during stable VA). The interval between 2 doses should not be shorter than 1 month arm 2: A PRN re-treatment scheme will be applied for the Ozurdex arm during this extension study, i.e. patients may receive an implant at V1E or later as needed: Patients should be monitored monthly and if there is a decline from stable VA stability due to macular edema patients will receive another intravitreal implant. (700 µg; long acting release (LAR)) given that in the opinion of the investigator the patient would benefit from the re-treatment. However, a minimum period of 5 months in between implantations is required.

Interventions: intervention 1: RFB002 intervention 2: Dexamethasone
Intervention descriptions: intervention 1: 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. Each vial contained ranibizumab in an aqueous solution (pH 5.5) with histidine, trehalose and polysorbate 20. intervention 2: Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone; 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. Dexamethasone had to be stored according to label instructions and it had to be kept in a secure locked facility

Protocol document: