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

NCT07073729 | Not Yet Recruiting

• 1 other identifier: CamachoNK2025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurotrophic Keratitis

Keywords

Corneal Neurotization; Cenergermin; Neurotrophic Keratopathy; Corneal Sensory Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in Corneal Sensitivity

  Measured using Cochet-Bonnet esthesiometry to evaluate restoration of corneal sensation following intervention.

  Baseline and 12 months post-treatment

Secondary Outcomes (2)

• Change in best-corrected visual acuity

  Baseline and 12 months post-intervention

• Overall Impact of the Procedure

  12 months

Study Arms (2)

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.

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.

Drug: Cenergermin

Interventions

Corneal Neurotization 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.

Also known as: Corneal Nerve Transfer, Corneal Sensory Nerve Grafting

Corneal Neurotization

Cenergermin 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.

Also known as: Oxervate

Cenergermin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Interventions

cenegermin

Study Officials

• Alex Camacho, MD, MSc

  Western University, Ophthalmology

  PRINCIPAL INVESTIGATOR

• Cindy Hutnik, MD, PhD, Department Chief

  Western University, Ophthalmology

  STUDY CHAIR

• Monali Malvankar, PhD, Professor

  Western University, Ophthalmology

  STUDY CHAIR

• Anastasiya Vinokurtseva, MD, Resident

  Western University, Ophthalmology

  STUDY CHAIR

Central Study Contacts

Alex Camacho, MD, MSc

CONTACT

519-646-6100; Alex.camacho@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking is used in this feasibility study. All parties are aware of the intervention received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)