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

Last updated: March 3, 2025
Sponsor: Emmecell
Overall Status: Completed

Phase

1

Condition

Atherosclerosis

Treatment

EO2002 low dose

EO2002

EO2002 mid dose

Clinical Study ID

NCT04894110
EMME-001
  • Ages > 21
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

All ocular criteria apply to study eye unless otherwise noted.

  1. Age ≥ 21 years.

  2. Phakic or Pseudophakic with a posterior chamber intraocular lens

  3. Symptomatic corneal edema associated with endothelial dysfunction which may besecondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.

Exclusion

Exclusion Criteria:

All ocular criteria apply to study eye unless otherwise noted.

  1. Other corneal disease

  2. Anterior chamber intraocular lens, Sutured or scleral-fixated intraocular lens.

  3. Macular disease that in the investigator and/or sponsor's opinion would limit theability of the subject to demonstrate improvement in BCVA.

  4. History of refractive surgery.

  5. Descemet membrane detachment.

  6. History of uveitis or other ocular inflammatory disease.

  7. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainageimplant).

  8. Intraocular pressure >21 or <7 mm Hg

  9. Prior incisional eye surgery within 3 months prior to study treatment or penetratingor endothelial keratoplasty.

  10. History of ocular neoplasm.

  11. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).

  12. Female who is pregnant, nursing, or planning to become pregnant, or who is ofchildbearing potential and not using a reliable means of contraception during thestudy.

  13. Subject is currently participating in or has participated within the last 3 monthsin any other clinical trial of an investigational drug by ocular or systemicadministration.

  14. Any concomitant medical or psychological condition that could interfere with studyparticipation or is otherwise not suitable for entry into the study in the opinionof the investigator.

Study Design

Total Participants: 42
Treatment Group(s): 4
Primary Treatment: EO2002 low dose
Phase: 1
Study Start date:
June 22, 2021
Estimated Completion Date:
October 03, 2024

Study Description

The study is designed to occur in 2 groups. The objective with the first group is to preliminarily evaluate the safety of 4 escalating doses. The purpose of the second group is to gather additional safety information on the 3 highest doses when administered according to a randomized schedule and evaluated by masked observers.

Group 1: Phase 1 prospective, multi-center, open-label, dose-escalation study designed to evaluate the safety and tolerability 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. Four doses will be studied in approximately 21 study participants that meet the inclusion/exclusion criteria. Safety and tolerability will be the primary focus for 26 weeks following treatment with EO2002.

Group 2: The three highest doses will be administered to up to 21 subjects in a randomized, double-masked design.

Connect with a study center

  • Los Angeles Location

    Greater Los Angeles, California 91208
    United States

    Site Not Available

  • Los Angeles Location

    Los Angeles, California 91208
    United States

    Site Not Available

  • San Diego Location

    San Diego, California 92122
    United States

    Site Not Available

  • Denver Location

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Miami Location

    Miami, Florida 33136
    United States

    Site Not Available

  • Palm Beach Gardens Location

    Palm Beach Gardens, Florida 33410
    United States

    Site Not Available

  • Atlanta Location

    Atlanta, Georgia 30339
    United States

    Site Not Available

  • Des Moines Location

    Des Moines, Iowa 50266
    United States

    Site Not Available

  • Kansas City Location

    Kansas City, Kansas 66211
    United States

    Site Not Available

  • Kansas City Location

    Overland Park, Kansas 66204
    United States

    Site Not Available

  • Boston Location

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Grand Rapids Location

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

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