NCT04627571

Corneal Nerves After Treatment With Cenegermin

Structural and Functional Changes of Corneal Innervation After Treatment With Cenegermin

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurotrophic Keratitis

Interventions

Type	Name	Description
DRUG	Cenegermin Ophthalmic Solution [Oxervate]	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.

Timeline

• Start date: 2022-05-23
• Primary completion: 2025-03-25
• Completion: 2025-03-25
• First posted: 2020-11-13
• Last updated: 2025-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study