Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Sponsor

Asociación para Evitar la Ceguera en México (Other)

Overall Status

Recruiting

CT.gov ID

NCT05636579

Collaborator

Emmecell (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Edema Corneal Endothelial Dystrophy Endothelial Dysfunction Fuchs Dystrophy Fuchs' Endothelial Dystrophy Bullous Keratopathy Pseudophakic Bullous Keratopathy Corneal Edema Pseudophakic	Biological: EO2002 Drug: Ripasudil	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 1, Multiple Dose, Open-Label Study to Assess the Safety and Tolerability of EO2002 Intracameral Injections With or Without Topical Ripasudil in the Treatment of Corneal Edema

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EO2002 with Ripasudil EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily	Biological: EO2002 Intracameral injection of magnetic human corneal endothelial cells (EO2002) Drug: Ripasudil Daily use of Ripasudil drops
Experimental: EO2002 without Ripasudil EO2002 injection at Day 0 and re-injection at Week 6	Biological: EO2002 Intracameral injection of magnetic human corneal endothelial cells (EO2002)

Arm

Intervention/Treatment

Experimental: EO2002 with Ripasudil

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

Biological: EO2002

Intracameral injection of magnetic human corneal endothelial cells (EO2002)

Drug: Ripasudil

Daily use of Ripasudil drops

Experimental: EO2002 without Ripasudil

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

Biological: EO2002

Intracameral injection of magnetic human corneal endothelial cells (EO2002)

Outcome Measures

Primary Outcome Measures

Safety and Tolerability of multiple doses of EO2002 [32 weeks]
Incidence of Treatment-Emergent Adverse Events

Secondary Outcome Measures

Central Corneal Thickness [32 weeks]
Changes in CCT compared to baseline
Best Corrected Visual Acuity [32 weeks]
Changes in BCVA compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Age ≥ 18 years.
Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.

Key Exclusion Criteria:

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

Other corneal disease
Anterior chamber intraocular lens
Sutured or scleral-fixated intraocular lens.
Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
History of refractive surgery.
History of Vitrectomy
Descemet membrane detachment.
History of uveitis or other ocular inflammatory disease.
History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
IOP >21 or <7 mm Hg
Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
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.
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.
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

Locations

	Site	City	State	Country	Postal Code
1	Asociacion para Evitar la Ceguera en Mexico	Mexico City	Cdmx	Mexico	04030

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México
Emmecell

Investigators

Principal Investigator: Valeria Sanchez Huerta, MD, Asociacion para Evitar la Ceguera

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asociación para Evitar la Ceguera en México

ClinicalTrials.gov Identifier:

NCT05636579

Other Study ID Numbers:

VSH-003

First Posted:

Dec 5, 2022

Last Update Posted:

Dec 5, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Corneal Edema

Fuchs' Endothelial Dystrophy

Edema

Study Results

No Results Posted as of Dec 5, 2022