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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04894110
Other study ID # EMME-001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date June 22, 2021
Est. completion date October 30, 2024

Study information

Verified date April 2024
Source Emmecell
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 42
Est. completion date October 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Intervention

Biological:
EO2002
EO2002 (magnetic human corneal endothelial cells [HCECs]) with and without endothelial brushing (EB) or Descemet Stripping (DS)
EO2002 low dose
Low dose of EO2002 (magnetic human corneal endothelial cells)
EO2002 mid dose
Mid dose of EO2002 (magnetic human corneal endothelial cells)
EO2002 high dose
High dose of EO2002 (magnetic human corneal endothelial cells)

Locations

Country Name City State
United States Atlanta Location Atlanta Georgia
United States Des Moines Location Des Moines Iowa
United States Grand Rapids Location Grand Rapids Michigan
United States Los Angeles Location Los Angeles California
United States Miami Location Miami Florida
United States Kansas City Location Overland Park Kansas
United States Palm Beach Gardens Location Palm Beach Gardens Florida
United States San Diego Location San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Emmecell

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of EO2002] 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 Effect of EO2002 (+/-EB or DS) on corneal thickness Evaluate the effect of a single injection of EO2002 (+/-EB or DS) on corneal thickness as determined by pachymetry 26 Weeks
Secondary Effect of EO2002 (+/-EB or DS) on best corrected visual acuity (BCVA). 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
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