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NCT Number: NCT04293549

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

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.

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Key information

Conditions

Neurotrophic Keratopathy

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophtalmology Clinic, G.d'Annunzio University

Chieti, 66013, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Oxervate

Primary outcomes

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

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Changes in Corneal Sensitivity

    Time frame: 8 weeks

    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.

  2. Changes of persistent epithelial defect and corneal ulcers

    Time frame: 8 weeks

    determined by corneal fluorescein staining at 4, 8 weeks as defined by the central reading center on clinical pictures

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2020
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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