drugset / Trial / NCT01535261

Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

NCT01535261

Phase 3 Completed 357 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-02
Primary completion
2015-03
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.5 mg Intravitreal