Study to Assess Safety and Tolerability of Multiple Doses of EO2002

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2025-12-09

Brief Summary

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The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.

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Detailed Description

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Conditions

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Corneal Edema Corneal Endothelial Dystrophy Endothelial Dysfunction Fuchs Dystrophy Fuchs' Endothelial Dystrophy Bullous Keratopathy Pseudophakic Bullous Keratopathy Corneal Edema Pseudophakic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EO2002 with Ripasudil

EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily

Group Type EXPERIMENTAL

EO2002

Intervention Type BIOLOGICAL

Intracameral injection of magnetic human corneal endothelial cells (EO2002)

Ripasudil

Intervention Type DRUG

Daily use of Ripasudil drops

EO2002 without Ripasudil

EO2002 injection at Day 0 and re-injection at Week 6

Group Type EXPERIMENTAL

EO2002

Intervention Type BIOLOGICAL

Intracameral injection of magnetic human corneal endothelial cells (EO2002)

Interventions

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EO2002

Intracameral injection of magnetic human corneal endothelial cells (EO2002)

Intervention Type BIOLOGICAL

Ripasudil

Daily use of Ripasudil drops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All ocular criteria apply to the study eye unless otherwise noted.

1. Age ≥ 18 years.
2. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
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 the study eye unless otherwise noted.

1. Other corneal disease
2. Anterior chamber intraocular lens
3. Sutured or scleral-fixated intraocular lens.
4. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
5. History of refractive surgery.
6. History of Vitrectomy
7. Descemet membrane detachment.
8. History of uveitis or other ocular inflammatory disease.
9. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
10. IOP \>21 or \<7 mm Hg
11. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.

11\. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).

13\. 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.

14\. 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.

15\. 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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No