NCT04922151

601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)

A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Pathological Myopic Choroidal Neovascularization (pmCNV)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• 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 pmCNV

Detailed description

Following a 14-day maximum screening period, patients will be randomized and followed for approximately 36 weeks. Treatment visits will be scheduled in 4-week intervals. After 1 initial injection of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 4 to week 32). 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 Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.

Conditions

• Pathological Myopic Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	601	intravitreal recombinant humanized anti-VEGF monoclonal antibody
DRUG	Ranibizumab	intravitreal recombinant humanized anti-VEGF monoclonal antibody

Timeline

• Start date: 2021-06-04
• Primary completion: 2023-01-31
• Completion: 2023-07-31
• First posted: 2021-06-10
• Last updated: 2021-06-10

Locations

1 site across 1 country: China