The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
DE-122 Injectable Solution
DE-122 Injectable Solution
DE-122 Injectable Solution
Unnamed facility
Mountain View, California, United States
Unnamed facility
Walnut Creek, California, United States
Unnamed facility
Jackson, Michigan, United States
Unnamed facility
Austin, Texas, United States
Unnamed facility
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.
BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \[0, 97\] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision.
Time frame: Baseline (Day1) and Day 90.
Change From Baseline in Central Subfield Thickness (CST) at Day 90.
Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.
Time frame: Baseline (Day1) and Day 90.
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DE-122 Injectable Solution
McAllen, Texas, United States