Corneal Nerves After Treatment With Cenegermin

Study Overview
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Brief Summary
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Neurotrophic keratopathy (NK) is a condition in which patients have fewer or complete absence of nerves in the cornea, characterized by the reduced or absent corneal sensation. The lack of nerves in the cornea also result in damages of the cornea and in severe situation the loss of the eye. Cenegermin (trade name Oxervate) is a nerve growth factor eye drops designed to treat NK, and currently, it is the only FDA-approved medication for this purpose. Even though cenegermin is effective in the majority of patients, there is a lack of understanding of how cenegermin works in the eye. In this study, investigators aim to determine the structural and functional effects of cenegermin on the cornea, using non-invasive technologies including in vivo confocal microscopy on study participants with NK over the course of a year.

Detailed Description
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Cenegermin (OxervateTM) is a recombinant human form of nerve growth factor developed by Dompé Farmaceutici S.p.A. for patients who are diagnosed with corneal epithelial defects due to moderate to severe stages of NK.

Official Title
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Structural and Functional Changes of Corneal Innervation After Treatment With Cenegermin

Conditions
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Neurotrophic Keratitis

Intervention / Treatment
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* Drug: Cenegermin Ophthalmic Solution [Oxervate]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients ≥18 years of age; AND Persistent corneal epitheliopathy that is refractory to treatments for ≥2 weeks; AND Evidence of decreased corneal sensitivity, defined as ≤45mm on Cochet-Bonnet esthesiometer, within the area of the persistent corneal epitheliopathy; AND Evidence of decreased corneal sensitivity, defined as above, in ≥1 corneal quadrant outside the persistent corneal epithelial defect. Exclusion Criteria Patients with severe neurotrophic keratopathy characterized by corneal stromal ulceration involving over 75% of the total central corneal thickness and impending perforation. Patients who have used cenegermin eyedrops, autologous serum eyedrops, plasma-rich plasma eyedrops, or umbilical cord eyedrops for the treatment of neurotrophic keratopathy 8 weeks prior to study recruitment. Corneal surgery (including keratoplasty or refractive surgical procedures) within three months before study enrollment. Presence of concurrent bacterial or fungal infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient Population<br>Patients diagnosed with neurotrophic keratopathy. | Drug: Cenegermin Ophthalmic Solution [Oxervate]<br>* An 8-week course of topical cenegermin eye drops given 6 times daily would be started in the affected eye, in conjunction with the pre-existing medical treatment for neurotrophic keratopathy. Patients will be followed-up at 4 weeks, 6 weeks, 8 weeks, 3 months, 6 months, 9 months and 12 months (±2 weeks at each time point) after treatment. At each visit, patients will be assessed to determine the corneal epithelial defect and corneal sensation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in corneal nerve fiber density (CNFD) | To determine the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of changes in CNFD | To determine the duration of the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cenegermin, neurotrophic keratopathy, corneal nerve, corneal sensation