OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

Neurotrophic Keratitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573647
• Other study ID #: IIR-2019-1139
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Sight Medical Doctors PLLC
• Contact: Brad Kligman, MD
• Phone: 516-627-0033
• Email: bkligman[@]sightmd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 This risk can last for many years even after the ulcer is no longer active.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
United States	SightMD	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Sight Medical Doctors PLLC	Dompé, US, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Esthesiometry	To quantitatively measure change in corneal esthesiometry during and after treatment of neurotrophic ulcers with Oxervate using Cochet-Bonnet esthesiometry	6 Months
Secondary	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