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Corneal Nerves After Treatment With Cenegermin

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ClinicalTrials.gov Identifier: NCT04627571
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Simon Fung, University of California, Los Angeles

Study Description
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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.


Condition or disease Intervention/treatment
Neurotrophic Keratitis Drug: Cenegermin Ophthalmic Solution [Oxervate]

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Structural and Functional Changes of Corneal Innervation After Treatment With Cenegermin
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patient Population
Patients diagnosed with neurotrophic keratopathy.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are 18 years of age or older, who have a persistent corneal epithelial defect due to neurotrophic keratopathy that is refractory to conventional non-surgical treatments for 2 weeks or more, and who fulfill the inclusion and exclusion criteria detailed above.
Criteria

Inclusion Criteria

  1. Patients ≥18 years of age; AND
  2. Persistent corneal epithelial defect that is refractory to conventional non-surgical 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 epithelial defect; 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 had been using or who are going to use autologous serum eyedrops, plasma-rich plasma eyedrops, or umbilical cord eyedrops for the treatment of neurotrophic keratopathy.
  3. Ocular surgery (including laser or refractive surgical procedures) within three months before study enrollment.
  4. Presence of concurrent bacterial or fungal infection.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627571


Contacts
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Contact: Simon Fung, MD 310-794-9581 simonfung@mednet.ucla.edu
Contact: Julliane Bacerdo, B.S. 310-794-5538 jbacerdo@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Julliane Bacerdo, B.S    310-794-5538    jbacerdo@mednet.ucla.edu   
Principal Investigator: Simon Fung, MD         
Sub-Investigator: Anthony Aldave, MD         
Sub-Investigator: Saba Al-Hashimi, MD         
Sub-Investigator: Sophie Deng, MD, PhD         
Sponsors and Collaborators
University of California, Los Angeles
More Information
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Additional Information:

Publications:

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Responsible Party: Simon Fung, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04627571    
Other Study ID Numbers: 20-000833
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Fung, University of California, Los Angeles:
cenegermin
neurotrophic keratopathy
corneal nerve
corneal sensation
Additional relevant MeSH terms:
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Keratitis
Corneal Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions