NCT05324774

Efficacy and Safety of 9MW0813 in Subjects With Diabetic Macular Edema

Phase III Clinical Study of the Efficacy and Safety of 9MW0813 and Aflibercept (EYLEA®) in Patients With Diabetic Macular Edema (DME) in a Multicenter, Randomized, Double-blind, Parallel Active-controlled Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase III clinical study of the efficacy and safety of 9MW0813 and aflibercept (EYLEA®) in patients with diabetic macular edema (DME) in a multicenter, randomized, double-blind, parallel active-controlled study.

Detailed description

This is a multi-center, randomized, double-blind, parallel controlled phase 3 clinical trial. The primary objective is to compare the similarity of clinical efficacy of intravitreal 9MW0813 injection and aflibercept intraocular injection (EYLEA®) in DME patients. The secondary objectives are to compare the similarity of safety, immunogenicity and pharmacokinetics of intravitreal 9MW0813 injection and aflibercept intraocular injection (EYLEA®) in DME patients.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	9MW0813	The active ingredient of 9MW0813 injection is recombinant human vascular endothelial growth factor receptor-antibody fusion protein. 9 doses(2mg) of the drug will be injected intravitreously.
DRUG	Aflibercept	Aflibercept (trade name: Eylea®/EYLEA®) is an anti-VEGF drug developed by Regeneron/Bayer. It is a fusion protein of human VEGFR1 and VEGFR2 extracellular domains and human immunoglobulin Fc segment genes. 9 doses(2mg) of the drug will be injected intravitreously.

Timeline

• Start date: 2022-02-28
• Primary completion: 2023-09-30
• Completion: 2024-07-30
• First posted: 2022-04-12
• Last updated: 2022-04-12

Locations

1 site across 1 country: China