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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
346
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 (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.
Beijing tongren hospital affliated to capital medical university
Beijing, Beijing Municipality, China
RECRUITINGChange from Baseline in Best Corrected Visual Acuity (BCVA)
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score
Time frame: 8 weeks
Change from Baseline in Central Retinal Thickness(CRT)
Change from Baseline in CRT as measured by optical coherence tomography
Time frame: 8 weeks
Incidence of adverse events
Time frame: 52 weeks
Immunogenicity of IVT injection of 9MW0813 and aflibercept
Anti-drug antibody (ADA) in serum is detected, ADA-positive samples will be subjected to titer analysis and neutralizing antibody (Nab) analysis
Time frame: 52 weeks
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