Neurotrophic UlcerNCT04573647
OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
An observational study of Neurotrophic Ulcer and Neurotrophic Keratitis, run by Sight Medical Doctors PLLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurotrophic Ulcer, Neurotrophic Keratitis, Neurotrophic Corneal Ulcer
- What is being tested?
- Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with stage 3 neurotrophic keratitis (ulcer)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
SightMD
Manhasset, New York, 11030
Brad Kligman, MD, 516-627-0033, bkligman@sightmd.com
Monique Murray, 516-627-0033, mmurray@sightmd.com
About this study
Official title: 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.
Read the 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
- Being tested
- Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]
- Keywords
- Neurotrophic Ulcer, Neurotrophic Keratoconjunctivitis, Optical Coherence Tomography, OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (2)
Esthesiometry
To quantitatively measure change in corneal esthesiometry during and after treatment of neurotrophic ulcers with Oxervate using Cochet-Bonnet esthesiometry
Measured: 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
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Oct 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurotrophic UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sight Medical Doctors PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- Dompé, US, Inc.
- Responsible party
- Principal investigator, Brad Kligman, MD, Sight Medical Doctors PLLC
- Investigators
- Brad Kligman, MD, Principal investigator, Sight Medical Doctors PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573647
- Sponsor's protocol ID
- IIR-2019-1139
- Status last verified
- Apr 2024
- First submitted
- 28 Sep 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31631965Micera 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.
PubMed 16716299
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Corneal Stromal Thickness Using Anterior Segment OCT Following Treatment of Neurotrophic Ulcers With Oxervate
- ClinicalTrials.gov ID
- NCT04573647
- Acronym / sponsor ID
- IIR-2019-1139
- Conditions
- Neurotrophic Ulcer, Neurotrophic Keratitis, Neurotrophic Corneal Ulcer, Neurotrophic Keratoconjunctivitis
- Keywords
- Neurotrophic Ulcer, Neurotrophic Keratoconjunctivitis, Optical Coherence Tomography, OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sight Medical Doctors PLLCUniversity, hospital or other
- Collaborators
- Dompé, US, Inc.
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with stage 3 neurotrophic keratitis (ulcer)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment group |
Primary outcome
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.
2 secondary outcomes
Esthesiometry
Time frame: 6 Months
Clinical resolution of epithelial defects
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 31631965Sheha 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.
- Background: PubMed 16716299Micera 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Kligman, MD principal investigator
Sight Medical Doctors PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurotrophic Ulcer and Neurotrophic Keratitis, run by Sight Medical Doctors PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brad Kligman, MD (516-627-0033, bkligman@sightmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stromal Thickness (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573647, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.