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

Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
Study ID
NCT05324592
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 9MW0813 — DRUG
    The active ingredient of 9MW0813 injection is recombinant human vascular endothelial growth factor receptor-antibody fusion protein. One dose(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. One dose(2mg) of the drug will be injected intravitreously.

Study Details

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).

Key Dates

Start date
Feb 26, 2021
Status verified
Mar 2022
Primary completion
Sep 24, 2021
Completion
Jan 25, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 9MW0813
  • Active Comparator: aflibercept

Primary Outcome Measure

Incidence of adverse events [ Time Frame: baseline to week 6 ]

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