An 8-week Follow-up to Evaluate the Renewal of Corneal Nerves Structure and Function in Patients With Neurotrophic Keratopathy Treated With Recombinant Human Nerve Growth Factor (rhNGF) Eyedrops

NCT04293549 | Completed FDA Drug

• 1 other identifier: UChieti01
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, longitudinal, cross-sectional, observational Study with a 8-week Follow-up to evaluate the renewal of corneal nerves structure and function in patients with Neurotrophic Keratopathy treated with recombinant human Nerve Growth Factor (rhNGF) eyedrops.

Conditions

Neurotrophic Keratopathy

Outcome Measures

Primary Outcomes (1)

• Changes of sub-basal nerve density, diameter and number of nerve branches

  evaluated by In Vivo Confocal Microscopy (IVCM). Confocal microscopic scanning was focused on central cornea and superior, inferior, nasal and temporal quadrants; for each zone, 5 frames at the level of the epithelium and basal lamina were obtained. Corneal sub-basal nerve morphology and density was traced using NeuronJ, plug-in of ImageJ. Nerve regeneration rate was calculated.

  8 weeks

Secondary Outcomes (2)

• Changes in Corneal Sensitivity

  8 weeks

• Changes of persistent epithelial defect and corneal ulcers

  8 weeks

Study Arms (2)

rhNGF group

Therapeutic contact lens use was discontinued during the duration of the study. Patients underwent clinical examination with corneal fluorescein staining, Schirmer I tear test, assessment of corneal sensitivity with Cochet-Bonnet aesthesiometer and morphological examination of the nerves by In Vivo Confocal Microscopy (IVCM) at baseline and after 4 and 8 weeks of treatment. Changes in the corneal epithelium and stroma were evaluated by slit lamp biomicroscopy and photo documentation of the cornea after fluorescein staining.

Drug: Cenegermin, recombinant human Nerve Growth Factor (rhNGF) eyedrops

control comparator group

control comparator group was matched for age and gender and underwent assessment of corneal sensitivity with Cochet-Bonnet aesthesiometer and morphological examination of the nerves by In Vivo Confocal Microscopy (IVCM) at baseline.

Interventions

Cenegermin, recombinant human Nerve Growth Factor (rhNGF) eyedrops DRUG

rhNGF 20µg/ml (Cenegermin) eyedrops, 1 drop every 2 hours (6 times a day) for 8 weeks. Patients underwent clinical examination with corneal fluorescein staining, Schirmer I tear test, assessment of corneal sensitivity with Cochet-Bonnet aesthesiometer and morphological examination of the nerves by In Vivo Confocal Microscopy (IVCM) at baseline and after 4 and 8 weeks of treatment

Also known as: Oxervate

rhNGF group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

18 patients (9 males and 9 females) were recruited from the Ocular Surface Service of G. d'Annunzio University of Chieti- Pescara and from the Division of Clinical Neuroscience, Department of Ophthalmology, University of Nottingham.

You may qualify if:

• Patients with documented moderate or severe neurotrophic keratopathy based on a recent new classification of NK, refractory to conventional non surgical treatments. The diagnosis was made on medical and ophthalmological history, slit lamp examination, aesthesiometry, in vivo confocal microscopy.
• Decreased corneal sensitivity on the area of corneal defect and on superior, inferior, nasal and temporal quadrants (≤ 4 cm using the Cochet-Bonnet aesthesiometer)
• Patients who satisfy all Informed Consent requirements. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed
• Patients with ability to understand and perform the treatment.

You may not qualify if:

• active infective keratitis or inflammation not related to NK in the affected eye.
• presence of corneal dystrophies.
• presence of glaucoma.
• Any other ocular disease requiring topical ocular treatment during the course of the study treatment period.
• History of any ocular surgery (including laser or refractive surgical procedures) within the three months before study enrolment. (An exception to the preceding statement will be allowed if the ocular surgery is considered to be the cause of the stage 2 or 3 NK).
• patients with known hypersensitivity to one of the components of the study or procedural medications (e.g. anaesthetic drops, fluorescein).
• Females currently pregnant

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

Ophtalmology Clinic, G.d'Annunzio University

Chieti, 66013, Italy

Location

MeSH Terms

Interventions

cenegermin; Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Leonardo Mastropasqua, Professor

  Ophtalmology Clinic, G. d'Annunzio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director, Professor

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: March 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

IT (1)