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

Overview

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.

Full Title of Study: “Phase 1 Clinical Study to Evaluate Safety and Tolerability of Magnetic Human Corneal Endothelial Cells in the Treatment of Corneal Edema”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 50K to 200K cells
  • Experimental: 50K to 200K cells with endothelial brushing
  • Experimental: 500K cells
  • Experimental: 500K cells with endothelial brushing

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • BVCA
    • Time Frame: 12 months
    • Best corrected visual acuity
  • Corneal thickness
    • Time Frame: 12 months
    • Decrease in corneal thickness

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Valeria Sanchez-Huerta
  • Collaborator
    • Emmecell
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Valeria Sanchez-Huerta, Academic Director – Asociación para Evitar la Ceguera en México
  • Overall Official(s)
    • Valeria Sanchez-Huerta, MD, Principal Investigator, Asociacion Para Evitar la Ceguera
  • Overall Contact(s)
    • Valeria Sanchez-Huerta, MD, +5210841400, valeriash@gmail.com

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