Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD
NCT ID: NCT06839339
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-02-18
2027-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AL-001 Dose 1
Injection of dose 1
AL-001
Administered via suprachoroidal space injection.
AL-001 Dose 2
Injection of dose 2
AL-001
Administered via suprachoroidal space injection.
Aflibercept
Intravitreal injection
Aflibercept
Intravitreal injection
Interventions
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AL-001
Administered via suprachoroidal space injection.
Aflibercept
Intravitreal injection
Eligibility Criteria
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Inclusion Criteria
2. The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
3. The study eye has response to anti-VEGF injections.
4. The subject or their legal representative agrees to participate in this study and signs a written ICF.
Exclusion Criteria
2. Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
3. Uncontrolled glaucoma in the study eye.
4. History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
5. Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
6. Ametropia (high myopia or high hyperopia) \> 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
7. Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
8. None of intraocular inflammation in the study eye.
9. Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.
50 Years
85 Years
ALL
No
Sponsors
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Beijing Anlong Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chinese Academy of Medical Sciences & Peking Union Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AL-001-02
Identifier Type: -
Identifier Source: org_study_id
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