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

Neurotrophic Keratopathy Clinical Trial

Official title:

In Vivo Evaluation of Corneal Nerves and Epithelial Healing After Treatment With Nerve Growth Factor for Neurotrophic Keratopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293549
• Other study ID #: UChieti01
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: March 2020
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This Study shows that topical treatment with Recombinant Nerve Growth Factor (rhNGF) improved corneal sensitivity and increased sub-basal nerves density, promoting corneal healing of persistent epithelial defects and corneal ulcers in patients with stage 2 and 3 NK

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neurotrophic Keratopathy

Intervention

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

Locations

Country	Name	City	State
Italy	Ophtalmology Clinic, G.d'Annunzio University	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Corneal Sensitivity	measured by the Cochet-Bonnet aesthesiometer at 4 and 8 weeks after start of the treatment. Corneal sensitivity is measured in each patient in cm. the filament was applied on the area of corneal defect and on superior, inferior, nasal and temporal quadrants.	8 weeks
Secondary	Changes of persistent epithelial defect and corneal ulcers	determined by corneal fluorescein staining at 4, 8 weeks as defined by the central reading center on clinical pictures	8 weeks