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

Mabwell Bioscience

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Drug: 9MW0813; Drug: Aflibercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT05324774

9MW0813-2021-CP301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 346 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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).

Main 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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346 participants in 2 patient groups

9MW0813

Experimental group

Treatment:

Drug: 9MW0813

aflibercept

Active Comparator group

Treatment:

Drug: Aflibercept