Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD

Sponsor
Beijing Anlong Biopharmaceutical Co., Ltd.
Study ID
NCT06839339
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Wet Age-related Macular Degeneration (wAMD)

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • AL-001 — DRUG
    Administered via suprachoroidal space injection.
  • Aflibercept — DRUG
    Intravitreal injection

Study Details

This Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will be randomized in Cohorts 1 and 2 to receive AL-001 administered via suprachoroidal space injection, Cohort 3 to receive Aflibercept.

Key Dates

Start date
Feb 18, 2025
Status verified
Feb 2025
Primary completion
Sep 30, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AL-001 Dose 1
    Injection of dose 1
  • Experimental: AL-001 Dose 2
    Injection of dose 2
  • Active Comparator: Aflibercept
    Intravitreal injection

Primary Outcome Measure

Evaluate the effect of AL-001 on BCVA [ Time Frame: Week 24 ]

Central Contacts