OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

Evaluation of Changes in Corneal Stromal Thickness Using Anterior Segment OCT Following Treatment of Neurotrophic Ulcers With Oxervate

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.

Study Overview

• Status: Recruiting
• Conditions: Neurotrophic Keratitis; Neurotrophic Ulcer; Neurotrophic Corneal Ulcer; Neurotrophic Keratoconjunctivitis
• Intervention / Treatment: 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 This risk can last for many years even after the ulcer is no longer active.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 Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Brad Kligman, MD; Phone Number: 516-627-0033; Email: bkligman@sightmd.com

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Recruiting
      • SightMD
      • Contact: Brad Kligman, MD; Phone Number: 516-627-0033; Email: bkligman@sightmd.com
      • Contact: Monique Murray; Phone Number: 516-627-0033; Email: mmurray@sightmd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults with stage 3 neurotrophic keratitis (ulcer)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stromal Thickness	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.	6 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sight Medical Doctors PLLC
• Collaborators: Dompé, US, Inc.
• Investigators: Principal Investigator: Brad Kligman, MD, Sight Medical Doctors PLLC

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimated): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: OCT; Optical Coherence Tomography; Neurotrophic Ulcer; Neurotrophic Keratoconjunctivitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Eye Diseases; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Eye Infections; Ulcer; Keratitis; Keratoconjunctivitis; Corneal Ulcer; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: IIR-2019-1139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No