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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04894110
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Emmecell

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
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 Biological: EO2002 Biological: EO2002 low dose Biological: EO2002 mid dose Biological: EO2002 high dose Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Group 1: Open-Label, Dose-Escalation Study Group 2: Randomized, double masked
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Safety

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894110


Contacts
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Contact: Emmecell Study Contact 650-769-4232 clinicaltrials@emmecell.com

Locations
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United States, California
San Diego Location Recruiting
San Diego, California, United States, 92122
Contact: Principal Investigator    650-769-4232    clinicaltrials@emmecell.com   
United States, Florida
Miami Location Recruiting
Miami, Florida, United States, 33136
Contact: Principal Investigator    650-769-4232    clinicaltrials@emmecell.com   
Palm Beach Gardens Location Recruiting
Palm Beach Gardens, Florida, United States, 33410
Contact: Principal Investigator    650-769-4232    clinicaltrials@emmecell.com   
United States, Iowa
Des Moines Location Recruiting
Des Moines, Iowa, United States, 50266
Contact: Principal Investigator    650-769-4232    clinicaltrials@emmecell.com   
United States, Massachusetts
Boston Location Recruiting
Boston, Massachusetts, United States, 02111
Contact: Principal Investigator    650-769-4232    clinicaltrials@emmecell.com   
Sponsors and Collaborators
Emmecell
Investigators
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Study Director: Noelia Kunzevitzky Emmecell
More Information
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Responsible Party: Emmecell
ClinicalTrials.gov Identifier: NCT04894110    
Other Study ID Numbers: EMME-001
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Corneal Dystrophies, Hereditary
Corneal Edema
Fuchs' Endothelial Dystrophy
Edema
 Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn