Neurotrophic Keratitis
Conditions
Keywords
cenegermin, neurotrophic keratopathy, corneal nerve, corneal sensation
Brief 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.
Detailed 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.
Interventions
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.
Sponsors
Dompé Farmaceutici S.p.A
University of California, Los Angeles
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in corneal nerve fiber density (CNFD) | 1 year | To determine the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of changes in CNFD | 1 year | To determine the duration of the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Presence/absence of Changes in Dry Eye Symptom | 1 year | To determine changes in dry eye symptom scores assessed by the Ocular Surface Disease Index in patients initiated on cenegermin for recalcitrant neurotrophic keratopathy. A score ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease. |
| Changes in Tear Production | 1 year | To determine the changes in tear production in patients initiated on cenegermin for recalcitrant neurotrophic keratopathy. |
| Changes in Tear Characteristics | 1 year | To determine the changes in tear film osmolarity in patients initiated on cenegermin for recalcitrant neurotrophic keratopathy. |
Countries
United States
Outcome results
None listed