Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study

NCT ID: NCT07073729

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-08-01

Brief 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). 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.

Conditions

Neurotrophic Keratitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Corneal Neurotization

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.

Group Type: EXPERIMENTAL

Corneal Neurotization

Intervention Type: PROCEDURE

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.

Cenergermin

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.

Group Type: ACTIVE_COMPARATOR

Cenergermin

Intervention Type: DRUG

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.

Interventions

Corneal Neurotization

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.

Intervention Type: PROCEDURE

Cenergermin

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.

Intervention Type: DRUG

Other Intervention Names

Corneal Nerve Transfer; Corneal Sensory Nerve Grafting; Oxervate

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Camacho, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Western University, Ophthalmology

Cindy Hutnik, MD, PhD, Department Chief

Role: STUDY_CHAIR

Western University, Ophthalmology

Monali Malvankar, PhD, Professor

Role: STUDY_CHAIR

Western University, Ophthalmology

Anastasiya Vinokurtseva, MD, Resident

Role: STUDY_CHAIR

Western University, Ophthalmology

Locations

Ivey Eye Institute, St. Joseph's Health Care London

London, Ontario, Canada

Countries

Canada

Central Contacts

Alex Camacho, MD, MSc

Role: CONTACT

Alex.camacho@sjhc.london.on.ca

519-646-6100

Other Identifiers

CamachoNK2025

Identifier Type: -

Identifier Source: org_study_id