OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

• ClinicalTrials.gov Identifier: NCT04573647
• Recruitment Status: Not yet recruiting
• First Posted: October 5, 2020
• Last Update Posted: October 5, 2020
• Sponsor: Sight Medical Doctors PLLC
• Collaborator: Dompé, US, Inc.
• Information provided by (Responsible Party): Brad Kligman, MD, Sight Medical Doctors PLLC

Tracking Information

• First Submitted Date: September 28, 2020
• First Posted Date: October 5, 2020
• Last Update Posted Date: October 5, 2020
• Estimated Study Start Date: October 1, 2020
• Estimated Primary Completion Date: January 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 28, 2020)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 28, 2020)

• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adults with stage 3 neurotrophic keratitis (ulcer)

Condition

• Neurotrophic Ulcer
• Neurotrophic Keratitis
• Neurotrophic Corneal Ulcer
• Neurotrophic Keratoconjunctivitis

Intervention

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.

Study Groups/Cohorts

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.

Intervention: Drug: Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]

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. Epub 2006 May 23.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 28, 2020): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 31, 2022
• Estimated Primary Completion Date: January 31, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04573647
• Other Study ID Numbers: IIR-2019-1139
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Brad Kligman, MD, Sight Medical Doctors PLLC
• Study Sponsor: Sight Medical Doctors PLLC
• Collaborators: Dompé, US, Inc.

Investigators

• Principal Investigator: Brad Kligman, MD; Sight Medical Doctors PLLC

• PRS Account: Sight Medical Doctors PLLC
• Verification Date: September 2020