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NCT Number: NCT06839339

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

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.

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Key information

Conditions

Wet Age-related Macular Degeneration (wAMD)

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

AL-001

Drug

Administered via suprachoroidal space injection.

aflibercept

Drug

Intravitreal injection

Primary outcomes

  1. Evaluate the effect of AL-001 on BCVA

    Time frame: Week 24

    Change in BCVA

Secondary outcomes

  1. Safety

    Time frame: Week 56

    Incidence of adverse events (AEs) and serious adverse events (SAEs)

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

    Time frame: Week 56

    Mean change from baseline in CRT as measured

Study contacts

Contact information is provided by the study sponsor or research team.

Anlong Bio

CONTACT

[email protected]

+86-010-80414166

Sponsors and collaborators

Lead sponsor

Beijing Anlong Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase II, Randomized, Positive-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Single Suprachoroidal Space Injection of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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