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| Name | Class |
|---|---|
| Emmecell | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EO2002 with Ripasudil | Experimental | EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily |
|
| EO2002 without Ripasudil | Experimental | EO2002 injection at Day 0 and re-injection at Week 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EO2002 | Biological | Intracameral injection of magnetic human corneal endothelial cells (EO2002) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of multiple doses of EO2002 | Incidence of Treatment-Emergent Adverse Events | 32 weeks |
| 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 |
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Inclusion Criteria:
All ocular criteria apply to the study eye unless otherwise noted.
Key Exclusion Criteria:
All ocular criteria apply to the study eye unless otherwise noted.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yara Luna | Contact | 55 39 53 12 25 | reclutamiento.proyectos@apec.com.mx |
| Name | Affiliation | Role |
|---|---|---|
| Valeria Sanchez Huerta, MD | Asociacion para Evitar la Ceguera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociacion para Evitar la Ceguera en Mexico | Recruiting | Mexico City | Mexico City | 04030 | Mexico |
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| Ripasudil | Drug | Daily use of Ripasudil drops |
|
| 32 weeks |
| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| C562745 | Corneal Dystrophy, Posterior Polymorphous, 1 |
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D003317 | Corneal Dystrophies, Hereditary |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C584679 | K-115 |
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