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

Beijing Anlong Biopharmaceutical Co., Ltd.

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Wet Age-related Macular Degeneration (wAMD)

Treatments: Drug: AL-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06707753

AL-001-01

Details and patient eligibility

About

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

AL-001 Dose 1

Experimental group

Description:

Injection of low dose

Treatment:

Drug: AL-001

AL-001 Dose 2

Experimental group

Description:

Injection of medium dose

Treatment:

Drug: AL-001

AL-001 Dose 3

Experimental group

Description:

Injection of high dose

Treatment:

Drug: AL-001