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.
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:
- fully understand this research and sign ICF; Willing to follow and be able to complete all study procedures;
- Age ≥ 50 years old, < 80 years old, male or female;
- Active CNV lesions in fovea and/or parafovea secondary to nAMD , which have not been treated in the study eye 3 months before screening;
- 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.
- CNV area of the study eye≥50% of the total lesion area.
Main Exclusion Criteria:
- 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;
- The study eye has scar, fibrosis, geographic atrophy and dense hard exudation under the fovea.
- CNV caused by non-nAMD exists in the study eye (such as trauma, pathological myopia, multifocal choroiditis, ocular histoplasmosis, vascular stripes, etc.);
- 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.);
- Intravitreous hemorrhage occurred in the study eye within 30 days before the first administration.
- 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;
- 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;
- 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.);
- The study eye has high myopia with diopter≥8D
- The study eye has refractive interstitial turbidity and/or myosis that affect fundus or OCT examination;
- 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);
- Scleromalacia exists in the study eye.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Ming Zhang, +86 18980601020, Zhangming-yangcp@163.com
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.
- Conditions
- Wet Age-related Macular Degeneration
- 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 group | Role | What they receive |
|---|---|---|
| Lucentis-0.5mg(Q4w) | Active comparator | It 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) | Experimental | It 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) | Experimental | It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.5mg. Receives: Drug: MW02 |
| MW02(Q8w) | Experimental | It 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.
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)
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.
- First posted28 Mar 2022
- Study start7 May 2021
- Primary completion15 May 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05297292
- Acronym / sponsor ID
- MW02-2020-CP301
- Conditions
- Wet Age-related Macular Degeneration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 433 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lucentis-0.5mg(Q4w) | Active comparator | Drug: LucentisIt is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 0.5mg. |
| MW02-1.0mg(Q4w) | Experimental | Drug: MW02It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.0mg. |
| MW02-1.5mg(Q4w) | Experimental | Drug: MW02It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.5mg. |
| MW02(Q8w) | Experimental | Drug: MW02It is administered once every 4 weeks for 3 consecutive times, and then once every 8 weeks for 48 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MW02MW02 is a recombinant anti-VEGF humanized monoclonal antibody injection. | Drug | MW02-1.0mg(Q4w), MW02-1.5mg(Q4w), MW02(Q8w) |
| LucentisAlso: ranibizumaba recombinant anti-VEGF humanized monoclonal antibody injection | Drug | Lucentis-0.5mg(Q4w) |
Primary outcome
Change from Baseline in Best Corrected Visual Acuity (BCVA)
Time frame: At week 52
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 52.
1 secondary outcome
Change from Baseline in BCVA
Time frame: baseline to week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.