AzTrials
AzTrials

Wet Age-related Macular DegenerationPhase 2/3NCT05297292

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

A Phase 2/3 study testing MW02 and Lucentis in people with Wet Age-related Macular Degeneration, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
MW02 and Lucentis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
433 participants
Where
1 siteChina
Study dates
7 May 2021to 30 Jun 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

ming zhang, professor contact

86+18980602122

Zhangming-yangcp@163.com

China1 site, 1 recruiting
  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Ming Zhang, +86 18980601020, Zhangming-yangcp@163.com

    Recruiting

Other trials in China

About this study

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)

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.

Being tested
MW02, Lucentis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MW02Drug

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

  • LucentisDrug

    Also called ranibizumab

    a recombinant anti-VEGF humanized monoclonal antibody injection

Study groups in NCT05297292
Study groupRoleWhat they receive
Lucentis-0.5mg(Q4w)Active comparatorIt is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 0.5mg.
Receives: Drug: Lucentis
MW02-1.0mg(Q4w)ExperimentalIt is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.0mg.
Receives: Drug: MW02
MW02-1.5mg(Q4w)ExperimentalIt is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.5mg.
Receives: Drug: MW02
MW02(Q8w)ExperimentalIt is administered once every 4 weeks for 3 consecutive times, and then once every 8 weeks for 48 weeks.
Receives: Drug: MW02

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At week 52

Secondary outcomes (1)
  1. Change from Baseline in BCVA

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

    Measured: baseline to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start7 May 2021
  3. Primary completion15 May 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
433 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297292
Sponsor's protocol ID
MW02-2020-CP301
Status last verified
Mar 2022
First submitted
17 Mar 2022
Last updated
28 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MW02 and Lucentis in people with Wet Age-related Macular Degeneration, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ming zhang, professor (86+18980602122, Zhangming-yangcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Best Corrected Visual Acuity (BCVA) (time frame: At week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in