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

NCT ID: NCT05324592

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2022-01-25

Brief Summary

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

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

9MW0813

Group Type: EXPERIMENTAL

9MW0813

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: 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.

Interventions

9MW0813

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.

Intervention Type: DRUG

Aflibercept

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.

Intervention Type: DRUG

Other Intervention Names

Eylea®

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with type 1 or type 2 diabetes with HbA1c ≤ 11.0%;

2. Use ETDRS chart BCVA ≥ 19 letters and ≤ 73 letters (approximately equivalent to Snellen chart equivalent 20/40 to 20/400);

3. Central retinal thickness (CRT) ≥ 300 μm, (using spectral domain optical coherence tomography);

4. BCVA ≥ 24 letters in the non-study eye (approximately 20/320 equivalent on the Snellen chart).

Exclusion Criteria

1. with proliferative diabetic retinopathy (PDR), excluding inactive, fibrotic PDR;

2. Vitreous hemorrhage within 30 days before the first administration;

3. 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;

4. 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.) ;

5. There are iris neovascularization;

6. 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.);

7. The investigator believes that the cataract may affect the judgment of the examination or test results, or requires surgical treatment during the test;

8. Aphakia (excluding intraocular lens) or posterior capsule defect (except for YAG laser posterior capsulotomy after intraocular lens implantation within 30 days);

9. History of vitrectomy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing tongren hospital affliated to capital medical university

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

9MW0813-2020-CP101

Identifier Type: -

Identifier Source: org_study_id