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Structural and Functional Changes of Corneal Innervation After Treatment With Cenegermin
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.
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.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
University of California, Los Angeles
Los Angeles, California, United States
Start Date
May 23, 2022
Primary Completion Date
March 25, 2025
Completion Date
March 25, 2025
Last Updated
April 1, 2025
8
ACTUAL participants
Cenegermin Ophthalmic Solution [Oxervate]
DRUG
Lead Sponsor
University of California, Los Angeles
Collaborators
NCT06999733
NCT04573647
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04276558