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| Name | Class |
|---|---|
| Emmecell | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment at time of surgery | Experimental | EO2002 intracameral injection |
|
| Treatment post surgery | Experimental | EO2002 intracameral injection |
|
| Treatment at time of or post surgery | Active Comparator | EO2002 intracameral injection |
|
| Sham injection at time of or post surgery | Sham Comparator | Sham injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EO2002 | Biological | Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of EO2002 | Incidence of Treatment-Emergent Adverse Events | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Cell Density | Changes in ECD compared to baseline | 26 weeks |
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Key Inclusion Criteria:
Exclusion Criteria:
All ocular criteria apply to study eye unless otherwise noted.
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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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| ID | Term |
|---|---|
| D002386 | Cataract |
| D055954 | Corneal Endothelial Cell Loss |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
| D005132 | Eye Manifestations |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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2 arms are masked as indicated and 2 arms are open label
|
| Sham injection | Other | Sham injection |
|
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |