OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

Status Recruiting

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.

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 This risk can last for many years even after the ulcer is no longer active.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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04573647
Study type	Observational
Source	Sight Medical Doctors PLLC
Contact	Brad Kligman, MD
Phone	516-627-0033
Email	bkligman@sightmd.com
Status	Recruiting
Phase
Start date	October 1, 2020
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT04552730` - Nerve Growth Factor for the Treatment of Cornea Disease
Completed	`NCT04276558` - REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients	Phase 2
Completed	`NCT04820010` - Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
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Terminated	`NCT05809245` - Corneal Neurotization as a Treatment for Neurotrophic Keratopathy	N/A
Withdrawn	`NCT05321251` - Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.	Phase 2/Phase 3
Terminated	`NCT03037450` - Miniinvasive Corneal Neurotization. A Pilot Study.	N/A
Not yet recruiting	`NCT06364657` - Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye
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Not yet recruiting	`NCT02707120` - Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis	Phase 4
Completed	`NCT01756456` - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.	Phase 1/Phase 2
Completed	`NCT02227147` - Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK	Phase 2
Recruiting	`NCT05552261` - DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
Recruiting	`NCT04909450` - Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects	Phase 1/Phase 2
Active, not recruiting	`NCT06411145` - Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.