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Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy
BACKGROUD: Cenegermin (Oxervate, Dompè Farmaceutici, Milan, IT), a recombinant human NGF, is a potentially healing new drug for neurotrophic keratopathy (NK), a rare but challenging disease affecting the cornea. To date, studies that evaluate its mid-term effect on corneal nerves and sensitivity are...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8862484/ https://www.ncbi.nlm.nih.gov/pubmed/35189948 http://dx.doi.org/10.1186/s13023-022-02237-5 |
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author | Pedrotti, Emilio Bonacci, Erika Chierego, Chiara De Gregorio, Alessandra Cozzini, Tiziano Brighenti, Tommaso Caldarella, Grazia Pastore, Giovanlorenzo Fasolo, Adriano Marchini, Giorgio |
author_facet | Pedrotti, Emilio Bonacci, Erika Chierego, Chiara De Gregorio, Alessandra Cozzini, Tiziano Brighenti, Tommaso Caldarella, Grazia Pastore, Giovanlorenzo Fasolo, Adriano Marchini, Giorgio |
author_sort | Pedrotti, Emilio |
collection | PubMed |
description | BACKGROUD: Cenegermin (Oxervate, Dompè Farmaceutici, Milan, IT), a recombinant human NGF, is a potentially healing new drug for neurotrophic keratopathy (NK), a rare but challenging disease affecting the cornea. To date, studies that evaluate its mid-term effect on corneal nerves and sensitivity are lacking. OBJECTIVE: To evaluate the recovery and morphology of subbasal corneal nerves in patients treated with Cenegermin for NK and assess their correlation with corneal sensitivity. METHODS: This prospective, observational case series study was carried out between May 2018 and August 2020 at the Ophthalmic Clinic of the University of Verona. Clinical evaluation, sensitivity, and in vivo confocal microscopy (IVCM) were performed in the central and all four corneal sectors at baseline, the end of therapy (8 weeks), and 2, 4, and 8 months after therapy. Consecutive patients with NK (stage 2–3), treated with Cenegermin (1 drop 6 times daily for 8 weeks), were enrolled. During each visit, Corneal nerve fiber length (CNFL), corneal nerve fiber total branch density (CTBD), corneal nerve fiber fractal dimension (CNFraD) and Cochet-Bonnet esthesiometry (CBE) were measured. RESULTS: We enrolled 18 patients. Complete NK healing was noted in 14/18(78%) patients after 8 weeks of treatment; then in 14(78%), 15(83%), and 13(72%) patients at 2-, 4-, and 8-months, respectively. Starting at 8 weeks through 4-month follow-up there was progressive improvement in CBE in all corneal sectors (p ≤ 0.01), which continued thereafter. There was significant corneal nerve regrowth especially in the peripheral cornea: centripetal progression starting at 8 weeks (CNFL and CNFrad) and significant branching starting at 2 months (CTBD), which continued through to the end of follow up. Sector-coupled IVCM and CBE findings correlated at all evaluations (all r ≥ 0.62 starting at 2 months, with highest values in the peripheral sectors). CONCLUSIONS: After Cenegermin we observed a subbasal corneal nerve regeneration, a recovery of sensitivity and a lasting epithelial healing, suggesting that the effect of its action persists several months after discontinuation in patients with NK. |
format | Online Article Text |
id | pubmed-8862484 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-88624842022-02-23 Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy Pedrotti, Emilio Bonacci, Erika Chierego, Chiara De Gregorio, Alessandra Cozzini, Tiziano Brighenti, Tommaso Caldarella, Grazia Pastore, Giovanlorenzo Fasolo, Adriano Marchini, Giorgio Orphanet J Rare Dis Research BACKGROUD: Cenegermin (Oxervate, Dompè Farmaceutici, Milan, IT), a recombinant human NGF, is a potentially healing new drug for neurotrophic keratopathy (NK), a rare but challenging disease affecting the cornea. To date, studies that evaluate its mid-term effect on corneal nerves and sensitivity are lacking. OBJECTIVE: To evaluate the recovery and morphology of subbasal corneal nerves in patients treated with Cenegermin for NK and assess their correlation with corneal sensitivity. METHODS: This prospective, observational case series study was carried out between May 2018 and August 2020 at the Ophthalmic Clinic of the University of Verona. Clinical evaluation, sensitivity, and in vivo confocal microscopy (IVCM) were performed in the central and all four corneal sectors at baseline, the end of therapy (8 weeks), and 2, 4, and 8 months after therapy. Consecutive patients with NK (stage 2–3), treated with Cenegermin (1 drop 6 times daily for 8 weeks), were enrolled. During each visit, Corneal nerve fiber length (CNFL), corneal nerve fiber total branch density (CTBD), corneal nerve fiber fractal dimension (CNFraD) and Cochet-Bonnet esthesiometry (CBE) were measured. RESULTS: We enrolled 18 patients. Complete NK healing was noted in 14/18(78%) patients after 8 weeks of treatment; then in 14(78%), 15(83%), and 13(72%) patients at 2-, 4-, and 8-months, respectively. Starting at 8 weeks through 4-month follow-up there was progressive improvement in CBE in all corneal sectors (p ≤ 0.01), which continued thereafter. There was significant corneal nerve regrowth especially in the peripheral cornea: centripetal progression starting at 8 weeks (CNFL and CNFrad) and significant branching starting at 2 months (CTBD), which continued through to the end of follow up. Sector-coupled IVCM and CBE findings correlated at all evaluations (all r ≥ 0.62 starting at 2 months, with highest values in the peripheral sectors). CONCLUSIONS: After Cenegermin we observed a subbasal corneal nerve regeneration, a recovery of sensitivity and a lasting epithelial healing, suggesting that the effect of its action persists several months after discontinuation in patients with NK. BioMed Central 2022-02-21 /pmc/articles/PMC8862484/ /pubmed/35189948 http://dx.doi.org/10.1186/s13023-022-02237-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Pedrotti, Emilio Bonacci, Erika Chierego, Chiara De Gregorio, Alessandra Cozzini, Tiziano Brighenti, Tommaso Caldarella, Grazia Pastore, Giovanlorenzo Fasolo, Adriano Marchini, Giorgio Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy |
title | Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy |
title_full | Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy |
title_fullStr | Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy |
title_full_unstemmed | Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy |
title_short | Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy |
title_sort | eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8862484/ https://www.ncbi.nlm.nih.gov/pubmed/35189948 http://dx.doi.org/10.1186/s13023-022-02237-5 |
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