Structural and Functional Changes of Corneal Innervation After Treatment With Cenegermin

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: No
View:

• 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.

Locations
United States
California
University of California, Los Angeles
Recruiting
Los Angeles
Contact Information
Primary
Simon Fung, MD
simonfung@mednet.ucla.edu
310-794-9581
Time Frame
Start Date: May 23, 2022
Estimated Completion Date: December 2024
Participants
Target number of participants: 40
Treatments
Patient Population
Patients diagnosed with neurotrophic keratopathy.
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov

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