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

NCT05324774 | Unknown Phase 3 DMC

• 1 other identifier: 9MW0813-2021-CP301
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

aflibercept; biosimilarity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of adverse events

  52 weeks

• Immunogenicity of IVT injection of 9MW0813 and aflibercept

  52 weeks

Study Arms (2)

9MW0813

EXPERIMENTAL

Drug: 9MW0813

aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept

Interventions

9MW0813 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.

9MW0813

Aflibercept 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.

Also known as: Eylea®

aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Beijing tongren hospital affliated to capital medical university

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Wenbin Wei, MD/PhD

CONTACT

010-58268486; tr_weiwenbin@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 12, 2022
• Study Start: February 28, 2022
• Primary Completion: September 30, 2023
• Study Completion: July 30, 2024
• Last Updated: April 12, 2022

Record last verified: 2022-03

Locations

CN (1)