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

NCT ID: NCT05324774

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2024-07-30

Brief Summary

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

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.

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.

9 doses(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.

9 doses(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.

9 doses(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.

9 doses(2mg) of the drug will be injected intravitreously.

Intervention Type: DRUG

Other Intervention Names

Eylea®

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old, gender is not limited;

2. Diagnosed with type 1 or type 2 diabetes, and HbA1c≤10.0%;

3. The visual impairment of the study eye was mainly caused by diabetic macular edema;

4. 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);

5. 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).

Exclusion Criteria

1. Active proliferative diabetic retinopathy (PDR) exists in the study eye;

2. 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) );

3. 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);

4. The study eye has erythema of the iris, vitreous hemorrhage or traction retinal detachment;

5. The study eye has poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma drug treatment);

6. 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;

7. The study eye has received vitreoretinal surgery in the past;

8. Aphakic (except intraocular lens) in the research eye.

• Minimum Eligible Age: 18 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

Site Status: RECRUITING

Countries

China

Central Contacts

Wenbin Wei, MD/PhD

Role: CONTACT

tr_weiwenbin@163.com

010-58268486 ext. 8001

Facility Contacts

Wenbin Wei, MD/PhD

Role: primary

tr_weiwenbin@163.com

010-58268486 ext. 8001

Other Identifiers

9MW0813-2021-CP301

Identifier Type: -

Identifier Source: org_study_id