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Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema

Phase 1 Clinical Study to Evaluate Safety and Tolerability of Magnetic Human Corneal Endothelial Cells in the Treatment of Corneal Edema

NCT04191629•Valeria Sanchez-Huerta

View on ClinicalTrials.gov

Summary

Single center, phase 1 study to evaluate the safety and tolerability of EO1404 in subjects with corneal edema secondary to pseudophakic bullous keratopathy or Fuch's endothelial dystrophy.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 21 years
•2. 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.
•a Symptoms including reduced vision and/or glare, and/or pain; subject may or may not have been on topical therapies such as 5% sodium chloride drops or prednisolone acetate 1% drops.
•b ETDRS-best corrected visual acuity worse than 20/63 on Snellen. c Central corneal thickness \< 2 mm by ultrasound pachymetry or OCT. d Subject must have progressed far enough in their clinical course to be considered a surgical candidate for full-thickness corneal transplantation or endothelial keratoplasty.
•4. Subject must understand and sign the informed consent. If the subject's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the subject in their maternal language.
•5. Subject must be medically able and willing to undergo the protocol-required procedures.

Exclusion Criteria

•All ocular criteria apply to study eye unless otherwise noted.
•1. Other corneal disease, including active or prior herpetic ocular infection; active inflammation; corneal scarring from trauma, burns, or infection; or band keratopathy.
•2. Visual acuity in the fellow eye is worse than 20/200.
•3. Anterior chamber intraocular lens.
•4. Subject requires topical, intravenous or oral acyclovir and/or related products during study duration
•5. History of vitrectomy.
•6. History of refractive surgery.
•7. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
•8. Prior incisional eye surgery within 3 months prior to study treatment.
•9. Subject is receiving systemic steroids or other systemic immunosuppressive medications.
+9 more criteria

Locations (1)

Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"

Mexico City, Mexico

Key Dates

Start Date

May 4, 2016

Primary Completion Date

December 31, 2020

Completion Date

February 28, 2021

Last Updated

December 10, 2019

Enrollment

ESTIMATED participants

Conditions

Corneal EdemaFuchs DystrophyFuchs' Endothelial DystrophyPseudophakic Bullous KeratopathyCorneal Endothelial DystrophyCorneal Transplant Failure

Interventions

EO1404

COMBINATION_PRODUCT

Endothelial brushing or Descemet stripping

PROCEDURE

Contacts

Valeria Sanchez-Huerta, MD

CONTACT

+5210841400 valeriash@gmail.com

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema

Inclusion Criteria

Exclusion Criteria

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