Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema
Public ClinicalTrials.gov record NCT04894110. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Prospective, Multi-Center, Open-Label, Dose-Escalation Study to Assess the Safety, and Tolerability of EO2002 with and Without Endothelial Brushing or Descemet Stripping in the Treatment of Corneal Edema (EMME-001)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04894110
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Interventions
- EO2002 Biological
- EO2002 low dose Biological
- EO2002 mid dose Biological
- EO2002 high dose Biological
Biological
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 22, 2021 (Actual)
- Primary completion
- Oct 3, 2024 (Actual)
- Completion
- Oct 3, 2024 (Actual)
- Last update posted
- Mar 5, 2025
2021 – 2024
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles Location | Greater Los Angeles | California | 91208 | — |
| San Diego Location | San Diego | California | 92122 | — |
| Miami Location | Miami | Florida | 33136 | — |
| Palm Beach Gardens Location | Palm Beach Gardens | Florida | 33410 | — |
| Atlanta Location | Atlanta | Georgia | 30339 | — |
| Des Moines Location | Des Moines | Iowa | 50266 | — |
| Kansas City Location | Overland Park | Kansas | 66204 | — |
| Grand Rapids Location | Grand Rapids | Michigan | 49546 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04894110, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 5, 2025 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04894110 live on ClinicalTrials.gov.