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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Wet Age-related Macular Degeneration
• Intervention / Treatment: Drug: Lucentis; Drug: MW02

• Study Type: Interventional
• Enrollment (Anticipated): 433
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: ming zhang, professor; Phone Number: 86+18980602122; Email: Zhangming-yangcp@163.com

Study Locations

• China
  • Si Chuan
    • Chengdu, Si Chuan, China
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Ming Zhang; Phone Number: +86 18980601020; Email: Zhangming-yangcp@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lucentis-0.5mg（Q4w）; It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 0.5mg.	Drug: Lucentis; a recombinant anti-VEGF humanized monoclonal antibody injection; Other Names: ranibizumab
EXPERIMENTAL: MW02-1.0mg（Q4w）; It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.0mg.	Drug: MW02; MW02 is a recombinant anti-VEGF humanized monoclonal antibody injection.
EXPERIMENTAL: MW02-1.5mg（Q4w）; It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.5mg.	Drug: MW02; MW02 is a recombinant anti-VEGF humanized monoclonal antibody injection.
EXPERIMENTAL: MW02（Q8w）; It is administered once every 4 weeks for 3 consecutive times, and then once every 8 weeks for 48 weeks.	Drug: MW02; MW02 is a recombinant anti-VEGF humanized monoclonal antibody injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in BCVA	Change from Baseline in BCVA as measured by ETDRS letter score over the study duration.	baseline to week 52

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2021
• Primary Completion (ANTICIPATED): May 15, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (ACTUAL): March 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: MW02-2020-CP301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No