Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD

Recruiting

• Conditions: Wet Age-related Macular Degeneration (wAMD)

• Registration Number: NCT06718816
• Lead Sponsor: Beijing Anlong Biopharmaceutical Co., Ltd.

Brief Summary

This study is designed to evaluate long-term safety and efficacy of AL-001 ophthalmic injection following suprachoroidal space(SCS) administration in subjects with wAMD. Eligible patients, are those who were previously enrolled in a clinical study in which they received a single dose of AL-001 administered via suprachoroidal space injection.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Study Start: 2024-12-09
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• The subjects enrolled in AL-001 study and received AL-001 ophthalmic injection.
• The subject or their legal representative agrees to participate in this study and signs a written ICF.
• The subjects are willing and able to follow planned visits and procedures.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AE/SAE	month 48	Incidence and severity of ophthalmic and systematic AE/SAE.

Secondary Outcome Measures

Name	Time	Method
The mean and frequency of anti-VEGF injections	month 48	The mean and frequency of subjects with wAMD receiving anti-VEGF injections
Best Corrected Visual Acuity(BCVA)	month 48	Change in BCVA from baseline

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences & Peking Union Hospital; 🇨🇳 Beijing, Beijing, China