OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

NCT ID: NCT04573647

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2024-12-31

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 This risk can last for many years even after the ulcer is no longer active.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

Conditions

Neurotrophic Ulcer; Neurotrophic Keratitis; Neurotrophic Corneal Ulcer; Neurotrophic Keratoconjunctivitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dompé, US, Inc.

UNKNOWN

Sponsor Role: collaborator

Sight Medical Doctors PLLC

OTHER

Sponsor Role: lead

Responsible Party

Brad Kligman, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brad Kligman, MD

Role: PRINCIPAL_INVESTIGATOR

Sight Medical Doctors PLLC

Locations

SightMD

Manhasset, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brad Kligman, MD

Role: CONTACT

bkligman@sightmd.com

516-627-0033

Facility Contacts

Brad Kligman, MD

Role: primary

bkligman@sightmd.com

516-627-0033

Monique Murray

Role: backup

mmurray@sightmd.com

516-627-0033

References

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.

Reference Type: BACKGROUND

PMID: 31631965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16716299 (View on PubMed)

Other Identifiers

IIR-2019-1139

Identifier Type: -

Identifier Source: org_study_id