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Recruiting NCT06718816

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

— Observational Wet Age-related Macular Degeneration (wAMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Wet Age-related Macular Degeneration (wAMD). Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Primary outcome measures

  • AE/SAE [Time frame: month 48]
Secondary outcome measures (2)
  • Best Corrected Visual Acuity(BCVA) [Time frame: month 48]
  • The mean and frequency of anti-VEGF injections [Time frame: month 48]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Chinese Academy of Medical Sciences & Peking Union Hospital — Beijing

Identifiers

NCT: NCT06718816 · AL-001-LT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗