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

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.

Study Overview

• Status: Unknown
• Conditions: Corneal Edema; Fuchs' Endothelial Dystrophy; Fuchs Dystrophy; Corneal Endothelial Dystrophy; Pseudophakic Bullous Keratopathy; Corneal Transplant Failure
• Intervention / Treatment: Combination product: EO1404; Procedure: Endothelial brushing or Descemet stripping

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Valeria Sanchez-Huerta, MD; Phone Number: 1234 +5210841400; Email: valeriash@gmail.com

Study Locations

• Mexico
  • Mexico City, Mexico, 04030
    • Recruiting
    • Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"
    • Contact: Sanchez-Huerta Valeria, MD; Phone Number: 1043 10841400
    • Principal Investigator: Sanchez-Huerta Valeria, MD
    • Sub-Investigator: De Wit Carter Guillermo, MD
    • Sub-Investigator: Hernandez-Chavarria Cesar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
10. 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.
11. History of uveitis or other ocular inflammatory disease.
12. History of glaucoma, or peripheral anterior synechiae on gonioscopy.
13. History of incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).
14. 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.
15. Subject is immunodeficient, or tested positive for HIV.
16. Subject is on chemotherapy.
17. History of malignancy other than basal cell carcinoma, UNLESS the malignancy was treated successfully 5 years prior to inclusion in the study.
18. History of ocular neoplasm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50K to 200K cells	Combination product: EO1404; Other Names: Magnetic Human Corneal Endothelial Cells
Experimental: 50K to 200K cells with endothelial brushing	Combination product: EO1404; Other Names: Magnetic Human Corneal Endothelial Cells; Procedure: Endothelial brushing or Descemet stripping
Experimental: 500K cells	Combination product: EO1404; Other Names: Magnetic Human Corneal Endothelial Cells
Experimental: 500K cells with endothelial brushing	Combination product: EO1404; Other Names: Magnetic Human Corneal Endothelial Cells; Procedure: Endothelial brushing or Descemet stripping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Adverse Events	Evaluation of safety adverse events including worsening of corneal edema and increase in intraocular pressure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BVCA	Best corrected visual acuity	12 months
Corneal thickness	Decrease in corneal thickness	12 months

Collaborators and Investigators

• Sponsor: Valeria Sanchez-Huerta
• Collaborators: Emmecell
• Investigators: Principal Investigator: Valeria Sanchez-Huerta, MD, Asociación para Evitar la Ceguera

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2016
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): February 28, 2021

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Edema; Corneal Edema; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: VSH01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No