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

Wet Age-related Macular Degeneration Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Positive-controlled, Seamless Design Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (Code MW02) in the Treatment of Neovascular (Wet) Age-related Macular Degeneration (nAMD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297292
• Other study ID #: MW02-2020-CP301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 7, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2022
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: ming zhang, professor
• Phone: 86+18980602122
• Email: Zhangming-yangcp[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 433
• Est. completion date: June 30, 2024
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Drug:
• MW02
MW02 is a recombinant anti-VEGF humanized monoclonal antibody injection.
• Lucentis
a recombinant anti-VEGF humanized monoclonal antibody injection

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Si Chuan

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at week 52.	At week 52
Secondary	Change from Baseline in BCVA	Change from Baseline in BCVA as measured by ETDRS letter score over the study duration.	baseline to week 52