Neurotrophic KeratitisNCT07073729
Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study
A study testing Corneal Neurotization and Cenergermin in people with Neurotrophic Keratitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This pilot study evaluates the feasibility and outcomes of two treatment approaches for corneal sensory dysfunction due to neurotrophic keratitis (NK): corneal neurotization surgery and topical Cenergermin (Oxervate). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neurotrophic Keratitis
- What is being tested?
- Corneal Neurotization and Cenergermin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years and older.
- Diagnosis of neurotrophic keratitis with reduced or absent corneal sensation.
- Clinical indication for either corneal neurotization surgery or topical Cenergermin treatment, as determined by the treating ophthalmologist.
- Ability to provide informed consent.
Who cannot join
- Active ocular infection or inflammation.
- Previous corneal neurotization procedure in the affected eye.
- Contraindications to general anesthesia or surgical intervention.
- Participation in another interventional clinical trial within the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Ivey Eye Institute, St. Joseph's Health Care London
London, Ontario, N6A 4V2
About this study
Official title: Corneal Neurotization: A Study on the Outcomes of Nerve Repair for Corneal Sensory Dysfunction
This pilot study evaluates the feasibility and outcomes of two treatment approaches for corneal sensory dysfunction due to neurotrophic keratitis (NK): corneal neurotization surgery and topical Cenergermin (Oxervate). Participants will receive treatment based on clinical decision-making, not randomization, and will be followed for 12 months through eight visits at the Ivey Eye Institute, St. Joseph's Health Care London. Data collected during routine eye examinations and validated quality-of-life questionnaires will be used to assess visual outcomes, corneal structure and function, and patient-reported well-being. This feasibility study is funded by the Lawson Research Institute Internal Research Fund and is intended to generate preliminary evidence for a future randomized trial.
Read the detailed description
Neurotrophic keratitis (NK) is a rare, progressive condition characterized by impaired corneal sensation and reduced nerve function. It affects approximately 5 in 10,000 individuals worldwide and more than 6,000 Canadians annually. If untreated, NK can lead to corneal scarring, ulceration, and irreversible vision loss. Two existing treatments are currently in use: corneal neurotization, a surgical technique that transfers healthy donor nerves to the cornea and topical Cenergermin (Oxervate), a recombinant human nerve growth factor that promotes epithelial healing and nerve regeneration.
This single-center, prospective pilot study is designed to assess the feasibility of conducting a larger comparative trial between these two treatment approaches. Specifically, the study will determine whether it is clinically and logistically feasible to compare outcomes between patients undergoing neurotization surgery and those receiving Cenergermin drops as part of their standard care.
Ten adult participants (aged ≥19) with moderate to severe NK will be recruited from the Ivey Eye Institute at St. Joseph's Health Care London. Participants will receive either surgical or medical treatment based on standard clinical care decisions. No additional interventions will be introduced for research purposes.
Participants will be followed across eight time points: baseline (before treatment), 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months. Each visit will include routine clinical evaluations such as corneal sensitivity testing, corneal nerve imaging, slit lamp exams, intraocular pressure, visual acuity and contrast testing, and a brief quality-of-life questionnaire.
All data will be collected through standard, non-invasive assessments during regular clinical follow-up. There will be no masking; both participants and clinicians will be aware of the assigned treatment.
This research is part of a pilot grant funded by the Lawson Health Research Institute and will provide critical data to inform the development of a larger, fully powered randomized controlled trial.
- Conditions
- Neurotrophic Keratitis
- Being tested
- Corneal Neurotization, Cenergermin
- Keywords
- Corneal Neurotization, Cenergermin, Neurotrophic Keratopathy, Corneal Sensory Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal NeurotizationProcedure or surgery
Also called Corneal Nerve Transfer, Corneal Sensory Nerve Grafting
Surgical technique involving the transfer of healthy donor sensory nerves to the anesthetic cornea to restore corneal innervation and sensation in patients with neurotrophic keratitis.
CenergerminDrug
Also called Oxervate
Topical recombinant human nerve growth factor (rhNGF) approved for the treatment of neurotrophic keratitis. Administered as eye drops, it promotes epithelial healing and nerve regeneration.
| Study group | Role | What they receive |
|---|---|---|
| Corneal Neurotization | Experimental | Participants in this arm will receive corneal neurotization surgery as part of their standard clinical care. The surgical procedure involves transferring healthy donor nerves to the anesthetic cornea in order to restore corneal sensation. Participants are followed over 12 months without randomization. Receives: Procedure: Corneal Neurotization |
| Cenergermin | Active comparator | Participants in this arm will receive topical Cenergermin (Oxervate) eye drops, a recombinant human nerve growth factor approved for treatment of neurotrophic keratitis. Treatment is selected based on clinical decision-making. Participants are followed over 12 months as part of routine care. Receives: Drug: Cenergermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corneal Sensitivity
Measured using Cochet-Bonnet esthesiometry to evaluate restoration of corneal sensation following intervention.
Measured: Baseline and 12 months post-treatment
Secondary outcomes (2)
Change in best-corrected visual acuity
Best-corrected visual acuity will be assessed using a standardized Snellen chart or equivalent method. The goal is to evaluate visual improvement following corneal neurotization or cenergermin treatment.
Measured: Baseline and 12 months post-intervention
Overall Impact of the Procedure
Comprehensive assessment of the overall effects of corneal neurotization, including clinical and functional outcomes as well as patient-reported measures of ocular comfort, perceived visual function, and general well-being at 12 months post-procedure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotrophic KeratitisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive either corneal neurotization surgery or Cenergermin (Oxervate) eye drops based on their clinical care plan. No randomization is used. The study will follow both groups over a 12-month period.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Camacho, MD, MSc, Principal investigator, Western University, OphthalmologyCindy Hutnik, MD, PhD, Department Chief, Study chair, Western University, OphthalmologyMonali Malvankar, PhD, Professor, Study chair, Western University, OphthalmologyAnastasiya Vinokurtseva, MD, Resident, Study chair, Western University, Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073729
- Sponsor's protocol ID
- CamachoNK2025
- Status last verified
- Jun 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan to share individual participant data (IPD) is currently under consideration and will depend on future institutional policies, data privacy constraints, and the outcomes of the study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Neurotization: A Study on the Outcomes of Nerve Repair for Corneal Sensory Dysfunction
- ClinicalTrials.gov ID
- NCT07073729
- Acronym / sponsor ID
- CamachoNK2025
- Conditions
- Neurotrophic Keratitis
- Keywords
- Corneal Neurotization, Cenergermin, Neurotrophic Keratopathy, Corneal Sensory Dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Jul 2025 (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.
This pilot study evaluates the feasibility and outcomes of two treatment approaches for corneal sensory dysfunction due to neurotrophic keratitis (NK): corneal neurotization surgery and topical Cenergermin (Oxervate). Participants will receive treatment based on clinical decision-making, not randomization, and will be followed for 12 months through eight visits at the Ivey Eye Institute, St. Joseph's Health Care London. Data collected during routine eye examinations and validated quality-of-life questionnaires will be used to assess visual outcomes, corneal structure and function, and patient-reported well-being. This feasibility study is funded by the Lawson Research Institute Internal Research Fund and is intended to generate preliminary evidence for a future randomized trial.
Detailed description
Neurotrophic keratitis (NK) is a rare, progressive condition characterized by impaired corneal sensation and reduced nerve function. It affects approximately 5 in 10,000 individuals worldwide and more than 6,000 Canadians annually. If untreated, NK can lead to corneal scarring, ulceration, and irreversible vision loss. Two existing treatments are currently in use: corneal neurotization, a surgical technique that transfers healthy donor nerves to the cornea and topical Cenergermin (Oxervate), a recombinant human nerve growth factor that promotes epithelial healing and nerve regeneration.
This single-center, prospective pilot study is designed to assess the feasibility of conducting a larger comparative trial between these two treatment approaches. Specifically, the study will determine whether it is clinically and logistically feasible to compare outcomes between patients undergoing neurotization surgery and those receiving Cenergermin drops as part of their standard care.
Ten adult participants (aged ≥19) with moderate to severe NK will be recruited from the Ivey Eye Institute at St. Joseph's Health Care London. Participants will receive either surgical or medical treatment based on standard clinical care decisions. No additional interventions will be introduced for research purposes.
Participants will be followed across eight time points: baseline (before treatment), 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months. Each visit will include routine clinical evaluations such as corneal sensitivity testing, corneal nerve imaging, slit lamp exams, intraocular pressure, visual acuity and contrast testing, and a brief quality-of-life questionnaire.
All data will be collected through standard, non-invasive assessments during regular clinical follow-up. There will be no masking; both participants and clinicians will be aware of the assigned treatment.
This research is part of a pilot grant funded by the Lawson Health Research Institute and will provide critical data to inform the development of a larger, fully powered randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will receive either corneal neurotization surgery or Cenergermin (Oxervate) eye drops based on their clinical care plan. No randomization is used. The study will follow both groups over a 12-month period.
| Arm | Type | Receives |
|---|---|---|
| Corneal Neurotization | Experimental | Procedure: Corneal NeurotizationParticipants in this arm will receive corneal neurotization surgery as part of their standard clinical care. The surgical procedure involves transferring healthy donor nerves to the anesthetic cornea in order to restore corneal sensation. Participants are followed over 12 months without randomization. |
| Cenergermin | Active comparator | Drug: CenergerminParticipants in this arm will receive topical Cenergermin (Oxervate) eye drops, a recombinant human nerve growth factor approved for treatment of neurotrophic keratitis. Treatment is selected based on clinical decision-making. Participants are followed over 12 months as part of routine care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 19 years and older.
- Diagnosis of neurotrophic keratitis with reduced or absent corneal sensation.
- Clinical indication for either corneal neurotization surgery or topical Cenergermin treatment, as determined by the treating ophthalmologist.
- Ability to provide informed consent.
Key exclusion criteria (4 listed)
- Active ocular infection or inflammation.
- Previous corneal neurotization procedure in the affected eye.
- Contraindications to general anesthesia or surgical intervention.
- Participation in another interventional clinical trial within the past 3 months.
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 |
|---|---|---|
| Corneal NeurotizationAlso: Corneal Nerve Transfer, Corneal Sensory Nerve GraftingSurgical technique involving the transfer of healthy donor sensory nerves to the anesthetic cornea to restore corneal innervation and sensation in patients with neurotrophic keratitis. | Procedure or surgery | Corneal Neurotization |
| CenergerminAlso: OxervateTopical recombinant human nerve growth factor (rhNGF) approved for the treatment of neurotrophic keratitis. Administered as eye drops, it promotes epithelial healing and nerve regeneration. | Drug | Cenergermin |
Primary outcome
Change in Corneal Sensitivity
Time frame: Baseline and 12 months post-treatment
Measured using Cochet-Bonnet esthesiometry to evaluate restoration of corneal sensation following intervention.
2 secondary outcomes
Change in best-corrected visual acuity
Time frame: Baseline and 12 months post-intervention
Overall Impact of the Procedure
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No. The plan to share individual participant data (IPD) is currently under consideration and will depend on future institutional policies, data privacy constraints, and the outcomes of the study.
Related trials for Neurotrophic Keratitis
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RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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RecruitingPhase 2
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
Neurotrophic Keratitis
RecruitingPhase 4
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
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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.
Alex Camacho, MD, MSc principal investigator
Western University, Ophthalmology
Cindy Hutnik, MD, PhD, Department Chief study chair
Western University, Ophthalmology
Monali Malvankar, PhD, Professor study chair
Western University, Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal Neurotization and Cenergermin in people with Neurotrophic Keratitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Jul 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Camacho, MD, MSc (519-646-6100, Alex.camacho@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Corneal Sensitivity (time frame: Baseline and 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2025.