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

Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
Study ID
NCT05324774
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 9MW0813 — DRUG
    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.
  • Aflibercept — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2022
Status verified
Mar 2022
Primary completion
Sep 30, 2023
Completion
Jul 30, 2024

Study Design

Enrollment
346 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 9MW0813
  • Active Comparator: aflibercept

Primary Outcome Measure

Change from Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: 8 weeks ]

Central Contacts

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