Clinical trial NCT04573647: OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
Official title: Evaluation of Changes in Corneal Stromal Thickness Using Anterior Segment OCT Following Treatment of Neurotrophic Ulcers With Oxervate
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurotrophic Ulcer
Neurotrophic Keratitis
Neurotrophic Corneal Ulcer
Neurotrophic Keratoconjunctivitis
Keywords: Neurotrophic Ulcer
Neurotrophic Keratoconjunctivitis
Optical Coherence Tomography
OCT
Lead sponsor: Sight Medical Doctors PLLC
Sponsor class: OTHER
Collaborators: name: Dompé, US, Inc.
First posted: 2020-10-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with stage 3 neurotrophic keratitis (ulcer)

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.

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 This risk can last for many years even after the ulcer is no longer active.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

Eligibility 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.

Primary outcomes:
measure: Stromal Thickness
timeFrame: 6 Months
Secondary outcomes:
measure: Esthesiometry
timeFrame: 6 Months
measure: Clinical resolution of epithelial defects
timeFrame: 6 Months
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: SightMD
state: New York
Study officials:
affiliation: Sight Medical Doctors PLLC
name: Brad Kligman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheha H, Tighe S, Hashem O, Hayashida Y. Update On Cenegermin Eye Drops In The Treatment Of Neurotrophic Keratitis. Clin Ophthalmol. 2019 Oct 7;13:1973-1980. doi: 10.2147/OPTH.S185184. eCollection 2019.
citation: Micera A, Lambiase A, Puxeddu I, Aloe L, Stampachiacchiere B, Levi-Schaffer F, Bonini S, Bonini S. Nerve growth factor effect on human primary fibroblastic-keratocytes: possible mechanism during corneal healing. Exp Eye Res. 2006 Oct;83(4):747-57. doi: 10.1016/j.exer.2006.03.010. Epub 2006 May 23.