CClinicalTrials.gg
Status unknownNCT05297292Updated Mar 28, 2022

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

A Phase 2/3 interventional study of MW02 and Lucentis in Wet Age-related Macular Degeneration, sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-28.

Sponsored by Mabwell (Shanghai) Bioscience Co., Ltd. · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2021, registered Mar 2022).
Phase
Phase 2/3
Study type
Interventional
Enrollment
433
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Wet Age-related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 433 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Mabwell (Shanghai) Bioscience Co., Ltd. is the lead sponsor of 53 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
433 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugMW02

    MW02 is a recombinant anti-VEGF humanized monoclonal antibody injection.

  • DrugLucentis

    a recombinant anti-VEGF humanized monoclonal antibody injection

    Also known as: ranibizumab

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At week 52

Secondary outcomes

  1. Change from Baseline in BCVA

    Change from Baseline in BCVA as measured by ETDRS letter score over the study duration.

    Time frame: baseline to week 52

07

Study locations

1 of 1 sites recruiting
  • West China Hospital of Sichuan University
    Chengdu, Si Chuan, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05297292
Lead sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
Responsible party
Sponsor
First posted
Mar 28, 2022
Start date
May 7, 2021
Primary completion
May 15, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Mar 28, 2022

Study contacts

ming zhang, professor
Contact
Zhangming-yangcp@163.com
86+18980602122

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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