Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction

Part of paid clinical trials in Menlo Park, California.

Sponsor
Emmecell
Study ID
NCT07729137
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Corneal Edema
  • Corneal Endothelial Cell Loss
  • Corneal Endothelial Decompensation
  • Corneal Endothelial Disorder
  • Corneal Endothelial Dystrophy 1
  • Endothelial Cell Loss, Corneal
  • Endothelial Corneal Dystrophy
  • Fuchs
  • Fuchs Dystrophy
  • Fuchs' Endothelial Dystrophy
  • Pseudophakic Bullous Keratopathy
  • Pseudophakic Bullous Keratopathy (PBK)

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 150K cells — BIOLOGICAL
    Intracameral injection - 150K dose
  • 500K cells — BIOLOGICAL
    Intracameral injection - 500K dose
  • Placebo — PROCEDURE
    Intracameral injection of vehicle

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
121 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 150K cells - EO2002
    Intracameral injection of 150K magnetic human corneal endothelial cells
  • Experimental: 500K cells - EO2002
    Intracameral injection of 500K magnetic human corneal endothelial cells
  • Placebo Comparator: Placebo
    Intracameral injection of vehicle (no cells)

Primary Outcome Measure

BCVA [ Time Frame: 26 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Site 1Menlo ParkCalifornia94025
Clinical Site 1
[email protected]
650-769-4232

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