Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Study Overview
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Brief Summary
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The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.

Official Title
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Phase 1, Multiple Dose, Open-Label Study to Assess the Safety and Tolerability of EO2002 Intracameral Injections With or Without Topical Ripasudil in the Treatment of Corneal Edema

Conditions
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Corneal Edema, Corneal Endothelial Dystrophy, Endothelial Dysfunction, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Bullous Keratopathy, Pseudophakic Bullous Keratopathy, Corneal Edema Pseudophakic

Intervention / Treatment
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* Biological: EO2002
* Drug: Ripasudil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All ocular criteria apply to the study eye unless otherwise noted. Age ≥ 18 years. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus). Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy. Key Exclusion Criteria: All ocular criteria apply to the study eye unless otherwise noted. Other corneal disease Anterior chamber intraocular lens Sutured or scleral-fixated intraocular lens. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA. History of refractive surgery. History of Vitrectomy Descemet membrane detachment. History of uveitis or other ocular inflammatory disease. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant). IOP >21 or <7 mm Hg Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty. 11. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200). 13. Female 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. 14. 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. 15. Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 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: EO2002 with Ripasudil<br>EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily | Biological: EO2002<br>* Intracameral injection of magnetic human corneal endothelial cells (EO2002)<br>Drug: Ripasudil<br>* Daily use of Ripasudil drops<br>|
| Experimental: EO2002 without Ripasudil<br>EO2002 injection at Day 0 and re-injection at Week 6 | Biological: EO2002<br>* Intracameral injection of magnetic human corneal endothelial cells (EO2002)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of multiple doses of EO2002 | Incidence of Treatment-Emergent Adverse Events | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Corneal Thickness | Changes in CCT compared to baseline | 32 weeks | 
| Best Corrected Visual Acuity | Changes in BCVA compared to baseline | 32 weeks |