Corneal Nerves After Treatment With Cenegermin

Active, not recruiting

• Conditions: Neurotrophic Keratitis
• Interventions: Drug: Cenegermin Ophthalmic Solution [Oxervate]

• Registration Number: NCT04627571
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2020-11-08
• Study First Submitted QC: 2020-11-08
• Study First Posted: 2020-11-13
• Study Start: 2022-05-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Population	Cenegermin Ophthalmic Solution [Oxervate]	Patients diagnosed with neurotrophic keratopathy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States