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

March 17, 2025 updated by: Beijing Anlong Biopharmaceutical Co., Ltd.

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Chinese Academy of Medical Sciences & Peking Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL-001 Dose 1
Injection of low dose
Drug: AL-001
Administered via suprachoroidal space injection.
Experimental: AL-001 Dose 2
Injection of medium dose
Drug: AL-001
Administered via suprachoroidal space injection.
Experimental: AL-001 Dose 3
Injection of high dose
Drug: AL-001
Administered via suprachoroidal space injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: Week 24
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of AL-001 on BCVA
Time Frame: Week 52
Mean change from baseline in BCVA
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anlong Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL-001-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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