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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05297292
Other study ID # MW02-2020-CP301
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT03585556 - AAVCAGsCD59 for the Treatment of Wet AMD Phase 1
Completed NCT03362190 - ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD) Phase 2
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Completed NCT03939767 - Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease
Completed NCT03066258 - Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial Phase 1/Phase 2
Terminated NCT01086761 - Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration Phase 1
Recruiting NCT05727397 - Efficacy and Safety of RC28-E Versus Aflibercept Phase 3
Completed NCT04884399 - Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD Phase 1
Completed NCT04964089 - A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) Phase 3
Withdrawn NCT01339949 - Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV) N/A
Terminated NCT00139282 - A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration Phase 3