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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Administered via suprachoroidal space injection.
Intravitreal injection
Chinese Academy of Medical Sciences & Peking Union Hospital
Beijing, China
Evaluate the effect of AL-001 on BCVA
Change in BCVA
Time frame: Week 24
Safety
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Week 56
Evaluate the effect of AL-001 on central retinal thickness (CRT)
Mean change from baseline in CRT as measured
Time frame: Week 56
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