Corneal Nerves After Treatment With Cenegermin

Status Recruiting

Clinical Trial Summary

Neurotrophic keratopathy (NK) is a condition in which patients have fewer or complete absence of nerves in the cornea, characterized by the reduced or absent corneal sensation. The lack of nerves in the cornea also result in damages of the cornea and in severe situation the loss of the eye. Cenegermin (trade name Oxervate) is a nerve growth factor eye drops designed to treat NK, and currently, it is the only FDA-approved medication for this purpose. Even though cenegermin is effective in the majority of patients, there is a lack of understanding of how cenegermin works in the eye. In this study, investigators aim to determine the structural and functional effects of cenegermin on the cornea, using non-invasive technologies including in vivo confocal microscopy on study participants with NK over the course of a year.

Clinical Trial Description

Cenegermin (OxervateTM) is a recombinant human form of nerve growth factor developed by Dompé Farmaceutici S.p.A. for patients who are diagnosed with corneal epithelial defects due to moderate to severe stages of NK. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04627571
Study type	Observational
Source	University of California, Los Angeles
Contact	Simon Fung, MD
Phone	310-794-9581
Email	simonfung@mednet.ucla.edu
Status	Recruiting
Phase
Start date	May 23, 2022
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT04552730` - Nerve Growth Factor for the Treatment of Cornea Disease
Completed	`NCT04276558` - REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients	Phase 2
Recruiting	`NCT04573647` - OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
Completed	`NCT04820010` - Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
Enrolling by invitation	`NCT05758753` - QST for Corneal Nerve Function	N/A
Terminated	`NCT05809245` - Corneal Neurotization as a Treatment for Neurotrophic Keratopathy	N/A
Withdrawn	`NCT05321251` - Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.	Phase 2/Phase 3
Terminated	`NCT03037450` - Miniinvasive Corneal Neurotization. A Pilot Study.	N/A
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Not yet recruiting	`NCT02707120` - Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis	Phase 4
Completed	`NCT01756456` - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.	Phase 1/Phase 2
Completed	`NCT02227147` - Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK	Phase 2
Recruiting	`NCT05552261` - DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
Recruiting	`NCT04909450` - Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects	Phase 1/Phase 2
Active, not recruiting	`NCT06411145` - Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis	Phase 4