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

NCT06839339 | Not Yet Recruiting Phase 2

• 1 other identifier: AL-001-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wet Age-related Macular Degeneration (wAMD)

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of AL-001 on BCVA

  Change in BCVA

  Week 24

Secondary Outcomes (2)

• Safety

  Week 56

• Evaluate the effect of AL-001 on central retinal thickness (CRT)

  Week 56

Study Arms (3)

AL-001 Dose 1

EXPERIMENTAL

Injection of dose 1

Drug: AL-001

AL-001 Dose 2

EXPERIMENTAL

Injection of dose 2

Drug: AL-001

Aflibercept

ACTIVE COMPARATOR

Intravitreal injection

Drug: Aflibercept

Interventions

AL-001 DRUG

Administered via suprachoroidal space injection.

AL-001 Dose 1; AL-001 Dose 2

Aflibercept DRUG

Intravitreal injection

Aflibercept

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 50 and ≤ 85.
• The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
• The study eye has response to anti-VEGF injections.
• The subject or their legal representative agrees to participate in this study and signs a written ICF.

You may not qualify if:

• Non-wAMD induced CNV or macular edema in the study eye.
• Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
• Uncontrolled glaucoma in the study eye.
• History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
• Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
• Ametropia (high myopia or high hyperopia) \> 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
• Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
• None of intraocular inflammation in the study eye.
• Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.

Sponsors & Collaborators

• Beijing Anlong Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Hospital

Beijing, China

Location

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Anlong Bio

CONTACT

+86-010-80414166; info@anlongbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

CN (1)