Conditions: Macular Edema Central Retinal Vein Occlusion
Keywords: Ophthalmology Ranibizumab Central Retinal Vein Occlusion
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 357
Healthy volunteers: no

Brief summary:
The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images was analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring was assessed in Year 2. The results of this open-label study provided long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.

Detailed description:

Arms:
arm 1: Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN

Interventions: intervention 1: Ranibizumab 0.5 mg/0.05 ml
Intervention descriptions: intervention 1: Patients will receive the first dose at Baseline, as an intravitreal injection with a standard dose of 0.5 mg/0.05 ml. Patients will receive at least 3 study treatments at monthly intervals (Day 1, Month 1 and Month 2). The last mandatory dose during treatment initiation will be administered approximately 60 days after the first study treatment. If there is no improvement in VA over the course of the first 3 injections, continued treatment is not recommended and the patient may receive alternative treatment at the investigator's discretion.

Protocol document: