OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

Sponsor

Sight Medical Doctors PLLC (Other)

Overall Status

Recruiting

CT.gov ID

NCT04573647

Collaborator

Dompé, US, Inc. (Other)

Enrollment

Location

32.9

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 This risk can last for many years even after the ulcer is no longer active.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 it is unclear 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.

Study Design

Study Type:

Observational

Anticipated 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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Stromal Thickness [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

Esthesiometry [6 Months]
To quantitatively measure change in corneal esthesiometry during and after treatment of neurotrophic ulcers with Oxervate using Cochet-Bonnet esthesiometry
Clinical resolution of epithelial defects [6 Months]
To evaluate time course of clinical resolution of epithelial defects in neurotrophic ulcers subjectively determined by slit lamp examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.