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

NCT ID: NCT06707753

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2025-08-31

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.

Conditions

Wet Age-related Macular Degeneration (wAMD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AL-001 Dose 1

Injection of low dose

Group Type: EXPERIMENTAL

AL-001

Intervention Type: DRUG

Administered via suprachoroidal space injection.

AL-001 Dose 2

Injection of medium dose

Group Type: EXPERIMENTAL

AL-001

Intervention Type: DRUG

Administered via suprachoroidal space injection.

AL-001 Dose 3

Injection of high dose

Group Type: EXPERIMENTAL

AL-001

Intervention Type: DRUG

Administered via suprachoroidal space injection.

Interventions

AL-001

Administered via suprachoroidal space injection.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anlong Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese Academy of Medical Sciences & Peking Union Hospital

Beijing, , China

Countries

China

Other Identifiers

AL-001-01

Identifier Type: -

Identifier Source: org_study_id