NCT06839339

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Beijing Anlong Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wet Age-related Macular Degeneration (wAMD)

Interventions

Type	Name	Description
DRUG	AL-001	Administered via suprachoroidal space injection.
DRUG	Aflibercept	Intravitreal injection

Timeline

• Start date: 2025-02-18
• Primary completion: 2026-09-30
• Completion: 2027-01-30
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: China