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NCT Number: NCT04627571

Corneal Nerves After Treatment With Cenegermin

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.

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Key information

Conditions

Neurotrophic Keratitis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cenegermin Ophthalmic Solution [Oxervate]

Drug

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.

Primary outcomes

  1. Change in corneal nerve fiber density (CNFD)

    Time frame: 1 year

    To determine the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy.

Secondary outcomes

  1. Duration of changes in CNFD

    Time frame: 1 year

    To determine the duration of the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy.

Other outcomes

  1. Presence/absence of Changes in Dry Eye Symptom

    Time frame: 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.

  2. Changes in Tear Production

    Time frame: 1 year

    To determine the changes in tear production in patients initiated on cenegermin for recalcitrant neurotrophic keratopathy.

  3. Changes in Tear Characteristics

    Time frame: 1 year

    To determine the changes in tear film osmolarity in patients initiated on cenegermin for recalcitrant neurotrophic keratopathy.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Dompé Farmaceutici S.p.A

Registry information

Official study title

Structural and Functional Changes of Corneal Innervation After Treatment With Cenegermin

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2020
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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