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Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema

NCT04894110 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-03-05

No results posted yet for this study

Summary

Corneal edema is the most common indication for corneal transplantation, accounting for approximately 70% of penetrating keratoplasty (PK), and 100% of endothelial keratoplasty (EK) procedures annually. There is currently no disease-modifying treatment for corneal edema. Topical treatments like hypertonic saline are not effective on a long-term basis. For those with advanced disease, where edema and vision loss are not controlled by topical treatment, the only option is a corneal transplant. A potential approach to avoidance of the risks of corneal transplantation is to inject cultured human corneal endothelial cells (HCECs) into the anterior chamber of the eye. This approach may avoid surgery by re-populating the inner most aspect of the cornea with functioning endothelial cells. Emmecell has developed a treatment based on technology integrating biocompatible magnetic nanoparticles with cultured HCECs to treat corneal edema in a minimally invasive way. The primary objective of this phase 1, prospective, multi-center, open-label, dose-escalation study is to evaluate the safety and tolerability of 3 doses of EO2002 with and without endothelial brushing (EB) or Descemet Stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that qualify for surgery involving full-thickness corneal transplantation or EK.

Conditions

  • Corneal Edema
  • Corneal Endothelial Dysfunction
  • Corneal Endothelial Dystrophy
  • Fuchs Dystrophy
  • Fuchs Endothelial Corneal Dystrophy
  • Pseudophakic Bullous Keratopathy
  • Bullous Keratopathy
  • Endothelial Dysfunction
  • Moderate Corneal Endothelial Decompensation

Interventions

BIOLOGICAL

EO2002

EO2002 (magnetic human corneal endothelial cells \[HCECs\]) with and without endothelial brushing (EB) or Descemet Stripping (DS)

BIOLOGICAL

EO2002 low dose

Low dose of EO2002 (magnetic human corneal endothelial cells)

BIOLOGICAL

EO2002 mid dose

Mid dose of EO2002 (magnetic human corneal endothelial cells)

BIOLOGICAL

EO2002 high dose

High dose of EO2002 (magnetic human corneal endothelial cells)

Sponsors & Collaborators

  • Emmecell

    lead INDUSTRY

Principal Investigators

  • Noelia Kunzevitzky · Emmecell

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2024-10-03
Completion
2024-10-03
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 NCT04894110 on ClinicalTrials.gov