NCT04667910

601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO)

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 Central Retinal Vein Occlusion (CRVO)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 Safety and efficacy outcomes will continue to be evaluated up to a period of 52 weeks unless the patient is withdrawn or discontinues the study.

Conditions

• Central Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	601 1.25mg	Solution for injection (intravitreal use)
DRUG	Ranibizuman 0.5 mg	Solution for injection (intravitreal use)

Timeline

• Start date: 2021-01-27
• Primary completion: 2022-11-16
• Completion: 2022-11-16
• First posted: 2020-12-16
• Last updated: 2025-06-27

Locations

1 site across 1 country: China