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601 Versus Ranibizumab in Patients With Branch Retinal Vein Occlusion (BRVO)

Branch Retinal Vein Occlusion Clinical Trial

Official title:
A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

Clinical Trial Summary

To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to macular edema secondary to BRVO

Clinical Trial Description

Following a 14-day maximum screening period, patients will be randomized and followed for approximately 52 weeks. Treatment visits will be scheduled in 4-week intervals. After 6 initial monthly injections of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 24 to week 48). During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 52 weeks unless the patient is withdrawn or discontinues the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04667897
Study type Interventional
Source Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Contact Hong Dai, Bachelor
Phone +86-010-85133308
Email dai-hong@x263.net
Status Not yet recruiting
Phase Phase 2
Start date December 2020
Completion date January 2023
View Details
See also
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