A Phase 2 interventional study of 150K cells and 500K cells in Corneal Edema, Fuchs and Fuchs Dystrophy, sponsored by Emmecell. Recruiting at 10 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Emmecell · Phase 2, Interventional, and Treatment
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.
39 studies on the registry are indexed under Corneal Edema; 8 are open to participants now.
This study's planned enrollment of 121 is above the median of 52 across 31 interventional studies indexed under Corneal Edema.
Browse Corneal Edema studies →Emmecell is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:
Key Exclusion Criteria:
Intracameral injection of 150K magnetic human corneal endothelial cells
Biological: 150K cells
Intracameral injection of 500K magnetic human corneal endothelial cells
Biological: 500K cells
Intracameral injection of vehicle (no cells)
Procedure: Placebo
Intracameral injection - 150K dose
Intracameral injection - 500K dose
Intracameral injection of vehicle
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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