A Study to Evaluate the Efficacy and Safety of MW02 in the Treatment of nAMD

Mabwell Bioscience

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Wet Age-related Macular Degeneration

Treatments: Drug: MW02; Drug: Lucentis

Study type: Interventional

Funder types: Industry

Identifiers

NCT05297292

MW02-2020-CP301

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of MW02 versus Lucentis in the treatment of neovascular age-related macular degeneration.The study was divided into two stages. The first stage was to explore the dose and the second stage was to explore the frequency of administration.

Enrollment: 433 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

1. fully understand this research and sign ICF; Willing to follow and be able to complete all study procedures;
2. Age ≥ 50 years old, < 80 years old, male or female;
3. Active CNV lesions in fovea and/or parafovea secondary to nAMD , which have not been treated in the study eye 3 months before screening;
4. The BCVA of the study eye is 73~24 letters (including boundary value), which is equivalent to 20/40 to 20/320 of Snellen's visual acuity chart.
5. CNV area of the study eye≥50% of the total lesion area.

Main Exclusion Criteria:

1. There is subretinal or intraretinal hemorrhage in the study eye, and the bleeding area is ≥ 50% of the total lesion area, or it is located in the fovea and the area is ≥ 1 optic disc area;
2. The study eye has scar, fibrosis, geographic atrophy and dense hard exudation under the fovea.
3. CNV caused by non-nAMD exists in the study eye (such as trauma, pathological myopia, multifocal choroiditis, ocular histoplasmosis, vascular stripes, etc.);
4. The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, macular epiretinal membrane, retinal pigment epithelium tear involving macular, vitreous macular traction syndrome, optic nerve disease, etc.);
5. Intravitreous hemorrhage occurred in the study eye within 30 days before the first administration.
6. The study eye has received the following intraocular surgery within 90 days, or has previously received various macular laser treatments (such as macular transposition, transpupillary thermotherapy, macular photocoagulation, vitrectomy, optic nerve incision, optic nerve sheath incision, etc.) (except those who have received Vitepofin-photodynamic therapy, cataract surgery and YAG posterior capsulotomy more than 3 months before screening) or have performed external eye surgery within 30 days;
7. The study eye has used corticosteroids in the eye or in the whole body within 3 months or injected corticosteroids around the globe within 30 days before the first administration;
8. The study eye has poorly controlled glaucoma (defined as intraocular pressure≥25 mmHg after anti-glaucoma treatment), and/or has received glaucoma filtering surgery (such as trabeculectomy, scleral bite, non-penetrating trabecular surgery, etc.);
9. The study eye has high myopia with diopter≥8D
10. The study eye has refractive interstitial turbidity and/or myosis that affect fundus or OCT examination;
11. Aphakia (except intraocular lens) or rupture of posterior capsule of lens (except YAG laser posterior capsulotomy after intraocular lens implantation more than 30 days before the first administration);
12. Scleromalacia exists in the study eye.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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433 participants in 4 patient groups

Lucentis-0.5mg（Q4w）

Active Comparator group

Description:

It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 0.5mg.

Treatment:

Drug: Lucentis

MW02-1.0mg（Q4w）

Experimental group

Description:

It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.0mg.

Treatment:

Drug: MW02

MW02-1.5mg（Q4w）

Experimental group

Description:

It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.5mg.

Treatment:

Drug: MW02

MW02（Q8w）

Experimental group

Description:

It is administered once every 4 weeks for 3 consecutive times, and then once every 8 weeks for 48 weeks.

Treatment:

Drug: MW02