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

Beijing Anlong Biopharmaceutical Co., Ltd.

Status and phase: Not yet enrolling; Phase 2

Conditions: Wet Age-related Macular Degeneration (wAMD)

Treatments: Drug: Aflibercept; Drug: AL-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06839339

AL-001-02

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥ 50 and ≤ 85.
2. The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
3. The study eye has response to anti-VEGF injections.
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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 3 patient groups

AL-001 Dose 1

Experimental group

Description:

Injection of dose 1

Treatment:

Drug: AL-001

AL-001 Dose 2

Experimental group

Description:

Injection of dose 2

Treatment:

Drug: AL-001

Aflibercept

Active Comparator group

Description:

Intravitreal injection

Treatment:

Drug: Aflibercept