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).
This is a multi-center, randomized, double-blind, parallel controlled Phase I clinical trial. The primary objective is to compare the safety of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients. The secondary objectives are to comparing the pharmacokinetic profile, immunogenicity and efficacy of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
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 (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.
Beijing tongren hospital affliated to capital medical university
Beijing, Beijing Municipality, China
Incidence of adverse events
Time frame: baseline to week 6
Peak Plasma Concentration(Cmax) of 9MW0813 and aflibercept
Pharmacokinetic measure
Time frame: baseline to week 6
Area under the plasma concentration versus time curve (AUC) of 9MW0813 and aflibercept
Pharmacokinetic measure
Time frame: baseline to week 6
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: baseline to week 6
Change 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: baseline to week 6
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