Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Intravitreal injection
EyePoint Investigational Site
Phoenix, Arizona, United States
EyePoint Investigational Site
Beverly Hills, California, United States
EyePoint Investigative Site
Mountain View, California, United States
Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population
Time frame: Week 48
Change in best corrected visual acuity (BCVA) by EDTRS
Mean change from Baseline in BCVA in the Study Eye
Time frame: Baseline, Week 48
Mean change in central subfield thickness (CST)
Mean change from Baseline in CST measured in microns by Spectral-domain - optical coherence tomography (OCT) assessments by a study-certified OCT technician in the study eye
Time frame: Baseline, Week 48
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EyePoint Investigational Site
Oxnard, California, United States
EyePoint Investigational Site
Melbourne, Florida, United States
EyePoint Investigational Site
St. Petersburg, Florida, United States
EyePoint Investigational Site
Springfield, Massachusetts, United States
EyePoint Investigative Site
Asheville, North Carolina, United States
EyePoint Investigational Site
Philadelphia, Pennsylvania, United States
EyePoint Investigational Site
Abilene, Texas, United States
...and 1 more locations