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

Study Overview
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Brief Summary
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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.

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

Conditions
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Corneal Endothelial Dystrophy, Corneal Edema, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Corneal Transplant Failure

Intervention / Treatment
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* Combination Product: EO1404
* Procedure: Endothelial brushing or Descemet stripping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Subject is immunodeficient, or tested positive for HIV. Subject is on chemotherapy. History of malignancy other than basal cell carcinoma, UNLESS the malignancy was treated successfully 5 years prior to inclusion in the study. History of ocular neoplasm.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50K to 200K cells<br> | Combination Product: EO1404<br> <br> * Other names: Magnetic Human Corneal Endothelial Cells;|
| Experimental: 50K to 200K cells with endothelial brushing<br> | Combination Product: EO1404<br> <br> * Other names: Magnetic Human Corneal Endothelial Cells;Procedure: Endothelial brushing or Descemet stripping<br> <br> |
| Experimental: 500K cells<br> | Combination Product: EO1404<br> <br> * Other names: Magnetic Human Corneal Endothelial Cells;|
| Experimental: 500K cells with endothelial brushing<br> | Combination Product: EO1404<br> <br> * Other names: Magnetic Human Corneal Endothelial Cells;Procedure: Endothelial brushing or Descemet stripping<br> <br> |

What is the study measuring?
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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 |