drugset / Trial / NCT05324592

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

NCT05324592

Phase 1 Completed 24 enrolled Mabwell (Shanghai) Bioscience Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A multicenter, randomized, double-blind, parallel-controlled phase I trial comparing the safety, pharmacokinetics and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose in patients with diabetic macular edema (DME).

Timeline

Start
2021-02-26
Primary completion
2021-09-24
Completion
2022-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject 9MW0813 Protein / enzyme biologic 2 mg Intravitreal
Comparator Aflibercept Protein / enzyme biologic 2 mg Intravitreal