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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-22

Study Completion Date

2024-10-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Group 1: Open-Label, Dose-Escalation Study Group 2: Randomized, double masked

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EO2002 treatment - Group 1

Group Type EXPERIMENTAL

EO2002

Intervention Type BIOLOGICAL

EO2002 (magnetic human corneal endothelial cells \[HCECs\]) with and without endothelial brushing (EB) or Descemet Stripping (DS)

EO2002 treatment - Group 2 - low dose

Group Type ACTIVE_COMPARATOR

EO2002 low dose

Intervention Type BIOLOGICAL

Low dose of EO2002 (magnetic human corneal endothelial cells)

EO2002 treatment - Group 2 - mid dose

Group Type ACTIVE_COMPARATOR

EO2002 mid dose

Intervention Type BIOLOGICAL

Mid dose of EO2002 (magnetic human corneal endothelial cells)

EO2002 treatment - Group 2 - high dose

Group Type ACTIVE_COMPARATOR

EO2002 high dose

Intervention Type BIOLOGICAL

High dose of EO2002 (magnetic human corneal endothelial cells)

Interventions

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EO2002

EO2002 (magnetic human corneal endothelial cells \[HCECs\]) with and without endothelial brushing (EB) or Descemet Stripping (DS)

Intervention Type BIOLOGICAL

EO2002 low dose

Low dose of EO2002 (magnetic human corneal endothelial cells)

Intervention Type BIOLOGICAL

EO2002 mid dose

Mid dose of EO2002 (magnetic human corneal endothelial cells)

Intervention Type BIOLOGICAL

EO2002 high dose

High dose of EO2002 (magnetic human corneal endothelial cells)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No