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

NCT07729137 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2026-07-29

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

PROCEDURE

Placebo

Intracameral injection of vehicle

BIOLOGICAL

150K cells

Intracameral injection - 150K dose

BIOLOGICAL

500K cells

Intracameral injection - 500K dose

Sponsors & Collaborators

  • Emmecell

    lead INDUSTRY

Principal Investigators

  • Noelia Kunzevitzky, PhD · Emmecell

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-08-31
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729137 on ClinicalTrials.gov