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RecruitingNCT06718816Updated Dec 5, 2024

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

An observational study in Wet Age-related Macular Degeneration (wAMD), sponsored by Beijing Anlong Biopharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Beijing Anlong Biopharmaceutical Co., Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
21
Ages
50 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Wet Age-related Macular Degeneration (wAMD)
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 21 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Beijing Anlong Biopharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
21 participants (estimated)
Patient registry
No

Groups and cohorts

  • The subjects received AL-001 ophthalmic injection

    Evaluate long-term safety and efficacy

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What researchers measure

Primary outcomes

  1. AE/SAE

    Incidence and severity of ophthalmic and systematic AE/SAE.

    Time frame: month 48

Secondary outcomes

  1. Best Corrected Visual Acuity(BCVA)

    Change in BCVA from baseline

    Time frame: month 48

  2. The mean and frequency of anti-VEGF injections

    The mean and frequency of subjects with wAMD receiving anti-VEGF injections

    Time frame: month 48

07

Study locations

1 of 1 sites recruiting
  • Chinese Academy of Medical Sciences & Peking Union Hospital
    Beijing, Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06718816
Lead sponsor
Beijing Anlong Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 5, 2024
Start date
Dec 9, 2024 (estimated)
Primary completion
Jun 30, 2029 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Dec 5, 2024

Study contacts

AnlongBio
Contact
info@anlongbio.com
+86-010-80414166

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Beijing Anlong Biopharmaceutical Co., Ltd.

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