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Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD
Sponsor: Beijing Anlong Biopharmaceutical Co., Ltd.
Summary
This Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will be randomized in Cohorts 1 and 2 to receive AL-001 administered via suprachoroidal space injection, Cohort 3 to receive Aflibercept.
Official title: A Phase II, Randomized, Positive-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Single Suprachoroidal Space Injection of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-02-18
Completion Date
2027-01-30
Last Updated
2025-02-21
Healthy Volunteers
No
Interventions
AL-001
Administered via suprachoroidal space injection.
Aflibercept
Intravitreal injection
Locations (1)
Chinese Academy of Medical Sciences & Peking Union Hospital
Beijing, China