This study is in progress, not accepting new patients

Corneal Nerves After Treatment With Cenegermin

a study on Neurotrophic Keratitis

Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Simon Fung

Description

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.

Official Title

Structural and Functional Changes of Corneal Innervation After Treatment With Cenegermin

Details

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.

Keywords

Neurotrophic Keratitis, cenegermin, neurotrophic keratopathy, corneal nerve, corneal sensation, Keratitis, Ophthalmic Solutions, Cenegermin Ophthalmic Solution [Oxervate]

Eligibility

You can join if…

Open to people ages 18-99

  1. Patients ≥18 years of age; AND
  2. Persistent corneal epitheliopathy that is refractory to treatments for ≥2 weeks; AND
  3. Evidence of decreased corneal sensitivity, defined as ≤45mm on Cochet-Bonnet esthesiometer, within the area of the persistent corneal epitheliopathy; AND
  4. Evidence of decreased corneal sensitivity, defined as above, in ≥1 corneal quadrant outside the persistent corneal epithelial defect.

You CAN'T join if...

  1. Patients with severe neurotrophic keratopathy characterized by corneal stromal ulceration involving over 75% of the total central corneal thickness and impending perforation.
  2. 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.
  3. Corneal surgery (including keratoplasty or refractive surgical procedures) within three months before study enrollment.
  4. Presence of concurrent bacterial or fungal infection.

Location

  • University of California, Los Angeles
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Simon Fung
    Assistant Professor-in-Residence, Ophthalmology, Medicine. Authored (or co-authored) 43 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
Links
Related Info
ID
NCT04627571
Study Type
Observational
Participants
Expecting 40 study participants
Last Updated