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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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)

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: 9MW0813
* Drug: Aflibercept


Participation Criteria
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Eligibility Criteria
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Main inclusion criteria： Diagnosed with type 1 or type 2 diabetes with HbA1c ≤ 11.0%; Use ETDRS chart BCVA ≥ 19 letters and ≤ 73 letters (approximately equivalent to Snellen chart equivalent 20/40 to 20/400); Central retinal thickness (CRT) ≥ 300 μm, (using spectral domain optical coherence tomography); BCVA ≥ 24 letters in the non-study eye (approximately 20/320 equivalent on the Snellen chart). Main exclusion criteria: with proliferative diabetic retinopathy (PDR), excluding inactive, fibrotic PDR; Vitreous hemorrhage within 30 days before the first administration; Structural retinal damage involving the fovea (such as retinal pigment epithelium (RPE) atrophy, retinal fibrosis, laser scarring, dense hard exudates), or the investigator believes that the study eye has other factors that may hinder vision after macular edema subsides increased retinal damage; Existing ophthalmic conditions other than diabetic retinopathy that cause macular edema or vision changes (such as retinal vein occlusion (RVO), choroidal neovascularization, retinal detachment, macular hole, macular retinal traction, epiretinal membrane, etc.) ; There are iris neovascularization; Uncontrolled glaucoma (defined as intraocular pressure ≥ 25mmHg after anti-glaucoma drug treatment) or glaucoma-causing cup/optic disc ratio of the study eye >0.8 or previous glaucoma filtering surgery (such as trabeculae); excision, sclerectomy, etc.); The investigator believes that the cataract may affect the judgment of the examination or test results, or requires surgical treatment during the test; Aphakia (excluding intraocular lens) or posterior capsule defect (except for YAG laser posterior capsulotomy after intraocular lens implantation within 30 days); History of vitrectomy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 9MW0813<br> | Drug: 9MW0813<br>* 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.<br>|
| Active Comparator: aflibercept<br> | Drug: Aflibercept<br>* 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.<br>* Other names: Eylea®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | baseline to week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration（Cmax） of 9MW0813 and aflibercept | Pharmacokinetic measure | baseline to week 6 | 
| Area under the plasma concentration versus time curve (AUC) of 9MW0813 and aflibercept | Pharmacokinetic measure | 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 | 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 | baseline to week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aflibercept, biosimilarity, safety, pharmacokinetics, pharmacodynamics