This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in subjects with refractory wet age-related macular degeneration (wAMD).
This study is designed to investigate the potential therapeutic effects and safety of oral ALK4290 administered 800 mg daily over a 6-week dosing period as measured by Best Corrected Visual Acuity (BCVA) in subjects with refractory wAMD (i.e., following monthly intravitreal \[IVT\] anti-VEGF therapy for at least 3 months in the study eye).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
ALK4290 400 mg tablet twice a day
Jahn Ferenc South-Pest Hospital and Clinic
Budapest, Hungary
Borsod-Abauj-Zemplen County Hospital and Teaching Hospital
Miskolc, Hungary
Szabolcs-Szatmar-Bereg County Hospital and University Hospital
Nyíregyháza, Hungary
University of Szeged Faculty of Medicine
Szeged, Hungary
Best Corrected Visual Acuity (BCVA)
Mean changes in BCVA as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) testing method. The ETDRS chart assesses changes in vision based on the number of letters correctly read by the subject
Time frame: Baseline to 6 weeks
Incidence of Treatment-emergent Adverse Events (Safety)
Treatment-emergent adverse events identified by the Common Terminology Criteria for Adverse Events (CTCAE v4.03)
Time frame: Baseline to 10 weeks
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Markusovszky University Teaching Hospital
Szombathely, Hungary