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NCT Number: NCT06718816

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

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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Key information

Conditions

Wet Age-related Macular Degeneration (wAMD)

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese Academy of Medical Sciences & Peking Union Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

YouxinChen

CONTACT

[email protected]

+86-010-65296358

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. AE/SAE

    Time frame: month 48

    Incidence and severity of ophthalmic and systematic AE/SAE.

Secondary outcomes

  1. Best Corrected Visual Acuity(BCVA)

    Time frame: month 48

    Change in BCVA from baseline

  2. The mean and frequency of anti-VEGF injections

    Time frame: month 48

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

Study contacts

Contact information is provided by the study sponsor or research team.

AnlongBio

CONTACT

[email protected]

+86-010-80414166

Sponsors and collaborators

Lead sponsor

Beijing Anlong Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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