Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD

December 2, 2024 updated by: Beijing Anlong Biopharmaceutical Co., Ltd.

A Long-term Follow-up Study to Evaluate the Safety and Effectivity of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Mecular Degeneration (wAMD)

This study is designed to evaluate long-term safety and efficacy of AL-001 ophthalmic injection following suprachoroidal space(SCS) administration in subjects with wAMD. Eligible patients, are those who were previously enrolled in a clinical study in which they received a single dose of AL-001 administered via suprachoroidal space injection.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

21

Contacts and Locations

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

Study Contact

Study Locations

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

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

Sampling Method

Non-Probability Sample

Study Population

Enrolled in AL-001-01 study and received AL-001 ophthalmic injection.

Description

Inclusion Criteria:

  • The subjects enrolled in AL-001 study and received AL-001 ophthalmic injection.
  • The subject or their legal representative agrees to participate in this study and signs a written ICF.
  • The subjects are willing and able to follow planned visits and procedures.

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
The subjects received AL-001 ophthalmic injection
Evaluate long-term safety and efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE/SAE
Time Frame: month 48
Incidence and severity of ophthalmic and systematic AE/SAE.
month 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity(BCVA)
Time Frame: month 48
Change in BCVA from baseline
month 48
The mean and frequency of anti-VEGF injections
Time Frame: month 48
The mean and frequency of subjects with wAMD receiving anti-VEGF injections
month 48

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 (Estimated)

December 9, 2024

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL-001-LT

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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