Study to Assess Safety and Tolerability 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 intracameral injection of EO2002 in subjects post-cataract surgery.

Official Title
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Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery

Conditions
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Cataract, Endothelial Cell Loss, Corneal

Intervention / Treatment
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* Biological: EO2002
* Other: Sham injection


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Age ≥ 18 years. Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery. Decreased endothelial cell count Exclusion Criteria: All ocular criteria apply to study eye unless otherwise noted. Other corneal disease Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA. Descemet membrane detachment. History of uveitis or other ocular inflammatory disease. History of incisional glaucoma surgery Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty. History of ocular neoplasm. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200). 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. 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. 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: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment at time of surgery<br>EO2002 intracameral injection | Biological: EO2002<br>* Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery<br>* Other names: Magnetic Human Corneal Endothelial Cells;|
| Experimental: Treatment post surgery<br>EO2002 intracameral injection | Biological: EO2002<br>* Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery<br>* Other names: Magnetic Human Corneal Endothelial Cells;|
| Active Comparator: Treatment at time of or post surgery<br>EO2002 intracameral injection | Biological: EO2002<br>* Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery<br>* Other names: Magnetic Human Corneal Endothelial Cells;|
| Sham Comparator: Sham injection at time of or post surgery<br>Sham injection | Other: Sham injection<br>* Sham injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of EO2002 | Incidence of Treatment-Emergent Adverse Events | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Cell Density | Changes in ECD compared to baseline | 26 weeks |