Clinical trial NCT05297292: A Study to Evaluate the Efficacy and Safety of MW02 in the Treatment of nAMD
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Wet Age-related Macular Degeneration
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 433
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change from Baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: At week 52
Secondary outcomes:
measure: Change from Baseline in BCVA
timeFrame: baseline to week 52
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Si Chuan
Study officials:
References: