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| Name | Class |
|---|---|
| Emmecell | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50K to 200K cells | Experimental |
| |
| 50K to 200K cells with endothelial brushing | Experimental |
| |
| 500K cells | Experimental |
| |
| 500K cells with endothelial brushing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EO1404 | Combination Product |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BVCA | Best corrected visual acuity | 12 months |
| Corneal thickness | Decrease in corneal thickness | 12 months |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valeria Sanchez-Huerta, MD | Contact | +5210841400 | 1234 | valeriash@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Valeria Sanchez-Huerta, MD | Asociacion Para Evitar la Ceguera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes" | Recruiting | Mexico City | 04030 | Mexico |
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| Endothelial brushing or Descemet stripping | Procedure |
|
| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| D005642 | Fuchs' Endothelial Dystrophy |
| C562745 | Corneal Dystrophy, Posterior Polymorphous, 1 |
| 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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