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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 CRVO


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 Safety and efficacy outcomes will continue to be evaluated up to a period of 52 weeks unless the patient is withdrawn or discontinues the study.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


NCT number NCT04667910
Study type Interventional
Source Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Contact Xiao rong Li, MD
Phone +86-022-23346434
Email xiaorli@163.com
Status Not yet recruiting
Phase Phase 2
Start date December 2020
Completion date January 2023

See also
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