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

Phase 1

Active, not recruiting

• Conditions: Wet Age-related Macular Degeneration (wAMD)
• Interventions: Drug: AL-001

• Registration Number: NCT06707753
• Lead Sponsor: Beijing Anlong Biopharmaceutical Co., Ltd.

Brief Summary

This Phase I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics 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 receive a single dose of AL-001 administered via suprachoroidal space injection.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Age≥ 50 and ≤ 80.
2. The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
3. Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥19.
4. The subject or their legal representative agrees to participate in this study and signs a written ICF.

Exclusion Criteria

1. Non-wAMD induced CNV or macular edema in the study eye.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AL-001 Dose 1	AL-001	Injection of low dose
AL-001 Dose 2	AL-001	Injection of medium dose
AL-001 Dose 3	AL-001	Injection of high dose

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	Week 24	Incidence of adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Name	Time	Method
Evaluate the effect of AL-001 on BCVA	Week 52	Mean change from baseline in BCVA

Trial Locations

Locations (1)

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