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

NCT04191629 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: VSH01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Edema; Fuchs Dystrophy; Fuchs' Endothelial Dystrophy; Pseudophakic Bullous Keratopathy; Corneal Endothelial Dystrophy; Corneal Transplant Failure

Outcome Measures

Primary Outcomes (1)

• Evaluation of Adverse Events

  Evaluation of safety adverse events including worsening of corneal edema and increase in intraocular pressure

  12 months

Secondary Outcomes (2)

• BVCA

  12 months

• Corneal thickness

  12 months

Study Arms (4)

50K to 200K cells

EXPERIMENTAL

Combination Product: EO1404

50K to 200K cells with endothelial brushing

EXPERIMENTAL

Combination Product: EO1404; Procedure: Endothelial brushing or Descemet stripping

500K cells

EXPERIMENTAL

Combination Product: EO1404

500K cells with endothelial brushing

EXPERIMENTAL

Combination Product: EO1404; Procedure: Endothelial brushing or Descemet stripping

Interventions

EO1404 COMBINATION_PRODUCT

Also known as: Magnetic Human Corneal Endothelial Cells

500K cells; 500K cells with endothelial brushing; 50K to 200K cells; 50K to 200K cells with endothelial brushing

Endothelial brushing or Descemet stripping PROCEDURE

500K cells with endothelial brushing; 50K to 200K cells with endothelial brushing

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 years
• Pseudophakic with a posterior chamber intraocular lens.
• 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.
• 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.
• Subject must be medically able and willing to undergo the protocol-required procedures.

You may not qualify if:

• All ocular criteria apply to study eye unless otherwise noted.
• Other corneal disease, including active or prior herpetic ocular infection; active inflammation; corneal scarring from trauma, burns, or infection; or band keratopathy.
• Visual acuity in the fellow eye is worse than 20/200.
• Anterior chamber intraocular lens.
• Subject requires topical, intravenous or oral acyclovir and/or related products during study duration
• History of vitrectomy.
• History of refractive surgery.
• Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
• Prior incisional eye surgery within 3 months prior to study treatment.
• Subject is receiving systemic steroids or other systemic immunosuppressive medications.
• 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.
• History of uveitis or other ocular inflammatory disease.
• History of glaucoma, or peripheral anterior synechiae on gonioscopy.
• History of incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).
• Female subject 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.

Sponsors & Collaborators

• Valeria Sanchez-Huerta: lead
• Emmecell: collaborator

Study Sites (1)

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

Mexico City, 04030, Mexico

RECRUITING

MeSH Terms

Conditions

Corneal Edema; Fuchs' Endothelial Dystrophy; Corneal Dystrophy, Posterior Polymorphous, 1

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Corneal Dystrophies, Hereditary; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Valeria Sanchez-Huerta, MD

  Asociacion Para Evitar la Ceguera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valeria Sanchez-Huerta, MD

CONTACT

+5210841400; valeriash@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Academic Director

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Study Start: May 4, 2016
• Primary Completion: December 31, 2020
• Study Completion: February 28, 2021
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)