Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 50K to 200K cells
|
Combination Product: EO1404
Other Names:
|
| Experimental: 50K to 200K cells with endothelial brushing
|
Combination Product: EO1404
Other Names:
Procedure: Endothelial brushing or Descemet stripping
|
| Experimental: 500K cells
|
Combination Product: EO1404
Other Names:
|
| Experimental: 500K cells with endothelial brushing
|
Combination Product: EO1404
Other Names:
Procedure: Endothelial brushing or Descemet stripping
|
Outcome Measures
Primary Outcome Measures
- Evaluation of Adverse Events [12 months]
Evaluation of safety adverse events including worsening of corneal edema and increase in intraocular pressure
Secondary Outcome Measures
- BVCA [12 months]
Best corrected visual acuity
- Corneal thickness [12 months]
Decrease in corneal thickness
Eligibility Criteria
Criteria
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.
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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.
-
Other corneal disease, including active or prior herpetic ocular infection; active inflammation; corneal scarring from trauma, burns, or infection; or band keratopathy.
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Visual acuity in the fellow eye is worse than 20/200.
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Anterior chamber intraocular lens.
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Subject requires topical, intravenous or oral acyclovir and/or related products during study duration
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History of vitrectomy.
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History of refractive surgery.
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Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
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Prior incisional eye surgery within 3 months prior to study treatment.
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Subject is receiving systemic steroids or other systemic immunosuppressive medications.
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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.
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History of uveitis or other ocular inflammatory disease.
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History of glaucoma, or peripheral anterior synechiae on gonioscopy.
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History of incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).
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Female subject 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.
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Subject is immunodeficient, or tested positive for HIV.
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Subject is on chemotherapy.
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History of malignancy other than basal cell carcinoma, UNLESS the malignancy was treated successfully 5 years prior to inclusion in the study.
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History of ocular neoplasm.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes" | Mexico City | Mexico | 04030 |
Sponsors and Collaborators
- Valeria Sanchez-Huerta
- Emmecell
Investigators
- Principal Investigator: Valeria Sanchez-Huerta, MD, Asociacion Para Evitar la Ceguera
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VSH01