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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06718816

Enrollment

Registered

2024-12-05

Start date

2024-12-09

Completion date

2029-06-30

Last updated

2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age-related Macular Degeneration (wAMD)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
AE/SAE	month 48	Incidence and severity of ophthalmic and systematic AE/SAE.

Secondary

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

Countries

China

Contacts

Primary ContactAnlongBio

info@anlongbio.com+86-010-80414166

Outcome results