Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD
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)
1 other identifier
observational
21
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2024
CompletedFirst Posted
Study publicly available on registry
December 5, 2024
CompletedStudy Start
First participant enrolled
December 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
December 5, 2024
December 1, 2024
4.6 years
December 2, 2024
December 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
AE/SAE
Incidence and severity of ophthalmic and systematic AE/SAE.
month 48
Secondary Outcomes (2)
Best Corrected Visual Acuity(BCVA)
month 48
The mean and frequency of anti-VEGF injections
month 48
Study Arms (1)
The subjects received AL-001 ophthalmic injection
Evaluate long-term safety and efficacy
Eligibility Criteria
Enrolled in AL-001-01 study and received AL-001 ophthalmic injection.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese Academy of Medical Sciences & Peking Union Hospital
Beijing, Beijing Municipality, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2024
First Posted
December 5, 2024
Study Start
December 9, 2024
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
December 5, 2024
Record last verified: 2024-12