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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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: Age ≥ 18 years old, gender is not limited; Diagnosed with type 1 or type 2 diabetes, and HbA1c≤10.0%; The visual impairment of the study eye was mainly caused by diabetic macular edema; OCT examination at screening and baseline, diabetic macular edema involving the fovea of the study eye, and central retinal thickness (CRT) ≥ 300 μm (using SD-OCT); The best-corrected visual acuity (BCVA) of the study eye at screening and baseline measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart was between 73 and 24 letters (inclusive) (approximately equivalent to Snellen's visual acuity) score 20/40 to 20/320). Main Exclusion Criteria: Active proliferative diabetic retinopathy (PDR) exists in the study eye; Structural damage to the fovea in the study eye, which may not improve BCVA after resolution of macular edema (eg, retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia, or organizing hard exudates) ); The study eye has any ocular disease or past medical history other than diabetic macular edema, and the investigator believes that it may affect the macular assessment or central vision (such as: cataract, retinal vascular occlusion, retinal detachment, macular traction, macular epiretinal membrane , macular hole, macular hemorrhage, preretinal fibrous proliferation involving the macula, various choroidal neovascularization); The study eye has erythema of the iris, vitreous hemorrhage or traction retinal detachment; The study eye has poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma drug treatment); The study eye has received or may have received glaucoma filtration surgery (such as: trabeculectomy, sclerectomy and non-penetrating trabecular surgery) during the study period; The study eye has received vitreoretinal surgery in the past; Aphakic (except intraocular lens) in the research eye.

Ages Eligible for Study
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Minimum Age: 18 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. 9 doses(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. 9 doses(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 |
| --- | --- | --- |
| 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 | 8 weeks | 
| Change from Baseline in Central Retinal Thickness（CRT） | Change from Baseline in CRT as measured by optical coherence tomography | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 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 | 52 weeks | 

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