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NCT Number: NCT06707753

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Wet Age-related Macular Degeneration (wAMD)

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chinese Academy of Medical Sciences & Peking Union Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age≥ 50 and ≤ 80.
  • The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
  • Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥19.
  • 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.

Primary outcomes

  1. Safety and tolerability

    Time frame: Week 24

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

Secondary outcomes

  1. Evaluate the effect of AL-001 on BCVA

    Time frame: Week 52

    Mean change from baseline in BCVA

Sponsors and collaborators

Lead sponsor

Beijing Anlong Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Nonrandomized, Single-arm, Single Dose, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Mar 19, 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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