Corneal Nerves After Treatment With Cenegermin

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Neurotrophic Keratitis

Treatments: Drug: Cenegermin Ophthalmic Solution [Oxervate]

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04627571

20-000833

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Trial design

8 participants in 1 patient group

Patient Population

Description:

Patients diagnosed with neurotrophic keratopathy.

Treatment:

Drug: Cenegermin Ophthalmic Solution [Oxervate]