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NOT YET RECRUITING
NCT06839339
PHASE2

Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD

Sponsor: Beijing Anlong Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

AL-001

Administered via suprachoroidal space injection.

DRUG

Aflibercept

Intravitreal injection

Locations (1)

Chinese Academy of Medical Sciences & Peking Union Hospital

Beijing, China