Spatial and temporal resolution of the photoreceptors rescue dynamics after treatment with voretigene neparvovec.


Journal

The British journal of ophthalmology
ISSN: 1468-2079
Titre abrégé: Br J Ophthalmol
Pays: England
ID NLM: 0421041

Informations de publication

Date de publication:
06 2022
Historique:
received: 30 10 2020
revised: 22 12 2020
accepted: 28 12 2020
pubmed: 22 1 2021
medline: 25 5 2022
entrez: 21 1 2021
Statut: ppublish

Résumé

Voretigene neparvovec is a gene therapeutic agent for treatment of retinal dystrophies caused by bi-allelic Seven eyes of five patients (14, 21, 23, 24, 36 years, 1 male, 4 females) with bi-allelic All except the oldest patient had a measurable improvement of the rod function assessed via FST, DAC or scotopic CPC at 1 month. The visual acuity improved slightly or remained stable in all eyes. A cone function improvement as measured by photopic CPC was observed in three eyes. The gain of the dark-adapted threshold with blue FST and the DAC stimuli (cyan) average correlated strongly with age (R The presented protocols allow evaluating the individual spatial and temporal effects of gene therapy effects. Additionally, we explored parameters that correlated with the success of the therapy. CPC and DAC present new and fast ways to assess functional changes in retinotopic maps of rod and cone function, measuring complementary aspects of retinal function.

Sections du résumé

BACKGROUND
Voretigene neparvovec is a gene therapeutic agent for treatment of retinal dystrophies caused by bi-allelic
METHODS
Seven eyes of five patients (14, 21, 23, 24, 36 years, 1 male, 4 females) with bi-allelic
RESULTS
All except the oldest patient had a measurable improvement of the rod function assessed via FST, DAC or scotopic CPC at 1 month. The visual acuity improved slightly or remained stable in all eyes. A cone function improvement as measured by photopic CPC was observed in three eyes. The gain of the dark-adapted threshold with blue FST and the DAC stimuli (cyan) average correlated strongly with age (R
CONCLUSIONS
The presented protocols allow evaluating the individual spatial and temporal effects of gene therapy effects. Additionally, we explored parameters that correlated with the success of the therapy. CPC and DAC present new and fast ways to assess functional changes in retinotopic maps of rod and cone function, measuring complementary aspects of retinal function.

Identifiants

pubmed: 33472769
pii: bjophthalmol-2020-318286
doi: 10.1136/bjophthalmol-2020-318286
pmc: PMC9132865
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

831-838

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: DF is or has been on the advisory board of and/or consulting and/or receiving honoraria/grant money/travel support from following companies: Adelphi Values, Advent France Biotechnology, Alphasights, Atheneum, Axiom Healthcare Strategies, Biogen, Decision Resources, Dialectica, EyeServ, Frontera Therapeutics, Janssen Research & Development, Navigant, Novartis, Roche, RegenxBio, Sirion and STZeyetrial. DF is director of Fischer Consulting Limited and holds a patent (50%) on a gene therapy product for X-linked Retinitis Pigmentosa. DF is the lead investigator of the global (ex-US) post-authorisation, multicentre, multinational, longitudinal, observational safety registry study for patients treated with voretigene neparvovec (CLTW888A12401) and a part of the data reported here are included in that study. EZ is or has been on the advisory board of and/or consulting and/or receiving honoraria/grant money/travel support from following companies: SMERUD, Atheneum, Axiom Healthcare strategies, Biogen, Decision Resources, Janssen Research & Development, Navigant, RegenxBio, ProQR, Gyroscope, Astellas and STZ eyetrial. KaS has received grants and/or travel reimbursement from Novartis, ProQR and ORA. SK and FW received personal fees from Novartis. BaW and TP received other support from Novartis.

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Auteurs

Krunoslav Stingl (K)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
Center for Rare Eye Diseases, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
Pupil Research Group at the University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Melanie Kempf (M)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
Center for Rare Eye Diseases, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Karl U Bartz-Schmidt (KU)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Spyridon Dimopoulos (S)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Felix Reichel (F)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Ronja Jung (R)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Carina Kelbsch (C)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
Pupil Research Group at the University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Susanne Kohl (S)

Molecular Genetics Laboratory, Institute for Ophthalmic Research, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Friederike Charlotte Kortüm (FC)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Fadi Nasser (F)

Institute for Ophthalmic Research, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Tobias Peters (T)

Pupil Research Group at the University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
STZ eyetrial at the Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Barbara Wilhelm (B)

Pupil Research Group at the University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
STZ eyetrial at the Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Bernd Wissinger (B)

Molecular Genetics Laboratory, Institute for Ophthalmic Research, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Fabian Wozar (F)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Eberhart Zrenner (E)

Center for Rare Eye Diseases, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
Institute for Ophthalmic Research, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
Werner Reichardt Centre for Integrative Neuroscience (CIN), University of Tübingen, Tübingen, Germany.

M Dominik Fischer (MD)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
Institute for Ophthalmic Research, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany.
Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK.
Nuffield Laboratory of Ophthalmology, Department of Clinical Neuroscience, University of Oxford, Oxford, UK.

Katarina Stingl (K)

University Eye Hospital, Center for Ophthalmology, University of Tübingen, Tübingen, Baden-Württemberg, Germany katarina.stingl@med.uni-tuebingen.de.
Center for Rare Eye Diseases, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

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