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OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04573647
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Dompé, US, Inc.
Information provided by (Responsible Party):
Brad Kligman, MD, Sight Medical Doctors PLLC

Brief Summary:
Neurotrophic keratitis (NK) is a condition where the cornea, or clear outer covering of the eye, has reduced sensation due to a variety of reasons. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. The purpose of this research is to find out if Oxervate (cenegermin-bkbj 0.002%) an FDA-approved treatment for neurotrophic corneal ulcers leads to an increase in thickness of the corneal stroma (middle layer of the cornea) during and after treatment of a neurotrophic ulcer. Corneal thickness will be measured using optical coherence tomography (OCT), a non-contact imaging device used routinely in ophthalmology examinations. Corneal sensation will also be measured during and after treatment with a device called a Cochet-Bonnet esthesiometer to see if the treatment increases corneal sensation.

Condition or disease Intervention/treatment
Neurotrophic Ulcer Neurotrophic Keratitis Neurotrophic Corneal Ulcer Neurotrophic Keratoconjunctivitis Drug: Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]

Detailed Description:

Neurotrophic keratitis (NK) is a condition where the cornea, or clear outer covering of the eye, has reduced sensation due to a variety of reasons such as previous surgery or infection. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. If the cornea becomes too thin, it is at risk for perforation or rupture, which requires extensive surgery to save vision and the eye. This risk can last for many years even after the ulcer is no longer active. The purpose of this research is to find out if Oxervate (cenegermin-bkbj 0.002%) an FDA-approved treatment for neurotrophic corneal ulcers leads to an increase in thickness of the corneal stroma (middle layer of the cornea) during and after treatment of a neurotrophic ulcer. The FDA trials demonstrated that Oxervate does lead to more rapid healing of the epithelium (thin surface layer) of the cornea, but we are still unsure if it increases the thickness of the stroma, which is the strongest part of the cornea. Corneal thickness will be measured using optical coherence tomography (OCT), a non-contact imaging device used routinely in ophthalmology examinations. Corneal sensation will also be measured during and after treatment with a device called a Cochet-Bonnet esthesiometer to see if the treatment increases corneal sensation. If treatment with Oxervate increases corneal sensation, then this decreases the risk of future ulcer formation.

About 10 subjects will take part in this research.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Changes in Corneal Stromal Thickness Using Anterior Segment OCT Following Treatment of Neurotrophic Ulcers With Oxervate
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment group
All participants in this trial will be in the treatment group. They will administer Oxervate following the FDA approved guidelines: 1 drop to the affected eye 6 times per day for 8 weeks.
Drug: Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]
Research subjects will use oxervate in affected eye following approved treatment regimen and have their eye measured with optical coherence tomography and a Cochet-Bonnet esthesiometer at various time points before, during and after treatment.




Primary Outcome Measures :
  1. Stromal Thickness [ Time Frame: 6 Months ]
    To determine with optical coherence tomography if stromal thickness at the thinnest point of a neurotrophic ulcer increases during and after treatment with Oxervate independent of corneal epithelium.


Secondary Outcome Measures :
  1. Esthesiometry [ Time Frame: 6 Months ]
    To quantitatively measure change in corneal esthesiometry during and after treatment of neurotrophic ulcers with Oxervate using Cochet-Bonnet esthesiometry

  2. Clinical resolution of epithelial defects [ Time Frame: 6 Months ]
    To evaluate time course of clinical resolution of epithelial defects in neurotrophic ulcers subjectively determined by slit lamp examination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults with stage 3 neurotrophic keratitis (ulcer)
Criteria

Inclusion Criteria:

  • Neurotrophic keratitis with stage 3 neurotrophic ulcer (stromal thinning)
  • Decreased corneal sensation relative to fellow eye determined qualitatively using wisp of cotton-tipped applicator to compare sensation in each eye without anesthesia.

Exclusion Criteria:

  • Impending corneal perforation (descemetocele)
  • Unable to physically complete diagnostic testing (cannot position head into slit lamp or OCT)
  • Unable to commit to 6 month follow up prior to initiating study
  • Unable to self-administer study drug following explanation and demonstration by PI and study coordinator
  • Active infectious infiltrate clinically worsening by history or clinical appearance
  • Pregnancy; patients must agree to use an acceptable form of birth control during study participation.

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): NCT04573647


Contacts
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Contact: Brad Kligman, MD 516-627-0033 bkligman@sightmd.com

Sponsors and Collaborators
Sight Medical Doctors PLLC
Dompé, US, Inc.
Investigators
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Principal Investigator: Brad Kligman, MD Sight Medical Doctors PLLC
Publications:
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Responsible Party: Brad Kligman, MD, Principle Investigator, Sight Medical Doctors PLLC
ClinicalTrials.gov Identifier: NCT04573647    
Other Study ID Numbers: IIR-2019-1139
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Brad Kligman, MD, Sight Medical Doctors PLLC:
Neurotrophic Ulcer
Neurotrophic Keratoconjunctivitis
Optical Coherence Tomography
OCT
Additional relevant MeSH terms:
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Corneal Ulcer
Keratitis
Keratoconjunctivitis
Ulcer
Pathologic Processes
Corneal Diseases
Eye Diseases
Conjunctivitis
Conjunctival Diseases
Eye Infections
Infection
Ophthalmic Solutions
Pharmaceutical Solutions