This study will evaluate the safety and effectiveness of a single injection of EO2002 at one of two dose levels (150,000 or 500,000 magnetic human corneal endothelial cells \[mHCECs\]), compared with a placebo injection, in participants with corneal edema caused by corneal endothelial dysfunction.
This study is designed to evaluate the safety and efficacy of EO2002, an investigational magnetic human corneal endothelial cell (mHCEC) therapy, in adults with corneal edema secondary to corneal endothelial dysfunction. Participants will be randomized to receive a single intracameral injection of one of two doses of EO2002 (150,000 or 500,000 cells) or placebo. The study will compare the effects of EO2002 on visual acuity and corneal thickness, while also evaluating safety over a 52-week follow-up period. Approximately 105 participants will be treated at multiple sites in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
Intracameral injection - 150K dose
Intracameral injection - 500K dose
Intracameral injection of vehicle
Clinical Site 1
Menlo Park, California, United States
BCVA
Proportion of study eyes achieving ≥ 15-letter best-corrected visual acuity (BCVA) improvement at 26 weeks post-treatment as compared to baseline.
Time frame: 26 weeks
BCVA
Mean change in BCVA compared to baseline
Time frame: 26 weeks
CCT
Mean change in CCT compared to baseline
Time frame: 26 weeks
BCVA
Proportion of subjects achieving ≥10-letter BCVA improvement from baseline
Time frame: 26 weeks
BCVA
Proportion of subjects achieving ≥70 letters (ETDRS)
Time frame: 26 weeks
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