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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-09

Study Completion Date

2029-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wet Age-related Macular Degeneration (wAMD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The subjects received AL-001 ophthalmic injection

Evaluate long-term safety and efficacy

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chinese Academy of Medical Sciences & Peking Union Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

AnlongBio

Role: CONTACT

Phone: +86-010-80414166

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

YouxinChen

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AL-001-LT

Identifier Type: -

Identifier Source: org_study_id