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

February 16, 2024 updated by: Emmecell

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 91208
      • San Diego, California, United States, 92122
    • Florida
      • Miami, Florida, United States, 33136
      • Palm Beach Gardens, Florida, United States, 33410
    • Georgia
      • Atlanta, Georgia, United States, 30339
    • Iowa
      • Des Moines, Iowa, United States, 50266
    • Kansas
      • Overland Park, Kansas, United States, 66204
    • Michigan
      • Grand Rapids, Michigan, United States, 49546

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.

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 the ability 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 drainage implant).
  8. Intraocular pressure >21 or <7 mm Hg
  9. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or 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 of childbearing potential and not using a reliable means of contraception during the study.
  13. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.
  14. Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EO2002 treatment - Group 1
Biological: EO2002
EO2002 (magnetic human corneal endothelial cells [HCECs]) with and without endothelial brushing (EB) or Descemet Stripping (DS)
Active Comparator: EO2002 treatment - Group 2 - low dose
Biological: EO2002 low dose
Low dose of EO2002 (magnetic human corneal endothelial cells)
Active Comparator: EO2002 treatment - Group 2 - mid dose
Biological: EO2002 mid dose
Mid dose of EO2002 (magnetic human corneal endothelial cells)
Active Comparator: EO2002 treatment - Group 2 - high dose
Biological: EO2002 high dose
High dose of EO2002 (magnetic human corneal endothelial cells)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of EO2002]
Time Frame: 26 Weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of EO2002 (+/- EB or Descemet Stripping)] in subjects with corneal edema at week 26.
26 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of EO2002 (+/-EB or DS) on corneal thickness
Time Frame: 26 Weeks
Evaluate the effect of a single injection of EO2002 (+/-EB or DS) on corneal thickness as determined by pachymetry
26 Weeks
Effect of EO2002 (+/-EB or DS) on best corrected visual acuity (BCVA).
Time Frame: 26 Weeks
Evaluate the effect of a single injection of EO2002 (+/-EB or DS) on best corrected visual acuity (BCVA) as determined by ETDRS letter score.
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emmecell

Investigators

  • Study Director: Noelia Kunzevitzky, Emmecell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2021

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 16, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMME-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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