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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: G. d'Annunzio University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Neurotrophic Keratopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2020-03-03
• Last updated: 2020-03-05

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study