Intravitreal decorin preventing proliferative vitreoretinopathy in perforating injuries: a pilot study

Abdussalam M Abdullatif; Tamer A Macky; Mona M Abdullatif; Khaled Nassar; Salvatore Grisanti; Hassan A Mortada; Mahmoud M Soliman

doi:10.1007/s00417-018-4105-7

Intravitreal decorin preventing proliferative vitreoretinopathy in perforating injuries: a pilot study

Titel in Übersetzung: Intravitreales Decorin verhindert proliferative Vitreoretinopathie bei perforierenden Verletzungen: eine Pilot Studie

Abdussalam M Abdullatif, Tamer A Macky, Mona M Abdullatif, Khaled Nassar, Salvatore Grisanti, Hassan A Mortada, Mahmoud M Soliman

Abstract

ZWECK: Zur Bestimmung der kurzfristigen Sicherheit von humanem rekombinantem Decorin-Protein bei der Verhinderung der proliferativen Vitreoretinopathie (PVR) bei Perforationsverletzungen.

METHODEN: Dies ist eine prospektive, einzentrige, offene, interventionelle Fallserie. Eine einmalige intravitreale Injektion von Decorin 200 μg (n = 4) oder 400 μg (n = 8) wurde 48 h nach der Verletzung verabreicht. Am zehnten Tag wurde, wann immer angezeigt, eine Pars-Plana-Vitrektomie durchgeführt. Das Flash-Elektroretinogramm (ERG) wurde vor und 3 Monate nach der Injektion durchgeführt. Wir untersuchten Augenentzündungen, ERG-Veränderungen und die Integrität der Netzhaut durch optische Kohärenztomographie (OCT). Die systematische und glasartige Pharmakokinetik wurde ebenfalls bewertet.

ERGEBNISSE: Zwölf Patienten (12 Augen) mit perforierenden Globusverletzungen (Zone III) wurden eingeschlossen und über einen Median von 6 Monaten beobachtet. Die intravitreale Decorin-Injektion wurde gut vertragen, ohne dass Nebenwirkungen auf die Augen oder die Systemsicherheit auftraten. Die Sicherheit der Netzhaut nach Decorin wurde anatomisch durch die intakte Netzhautschicht mittels OCT und funktionell durch das Flash-ERG nachgewiesen, das während der Studie keine signifikante Verschlechterung aufwies 0,7 (20/100) für die Gruppen A bzw. B und ≥ 20/200 bei 75% aller Augen. Die Decorin-Serum- und Glaskörperspiegel waren nach einem Trauma erhöht, während die Spiegel nach einer intravitrealen Injektion höher und länger waren.

Titel in Übersetzung	Intravitreales Decorin verhindert proliferative Vitreoretinopathie bei perforierenden Verletzungen: eine Pilot Studie
Originalsprache	Englisch
Zeitschrift	Graefe's Archive for Clinical and Experimental Ophthalmology
Jahrgang	256
Ausgabenummer	12
Seiten (von - bis)	2473-2481
Seitenumfang	9
ISSN	0721-832X
DOIs	https://doi.org/10.1007/s00417-018-4105-7
Publikationsstatus	Veröffentlicht - 2018

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10.1007/s00417-018-4105-7

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@article{a9353d62de794ade89f8226433ab4051,

title = "Intravitreal decorin preventing proliferative vitreoretinopathy in perforating injuries: a pilot study",

abstract = "PURPOSE: To determine the short-term safety of human recombinant decorin protein in preventing proliferative vitreoretinopathy (PVR) in perforating injuries.METHODS: This is a prospective, single-center, open-label, interventional case series. Single intravitreal injection of decorin 200 μg (n = 4) or 400 μg (n = 8) was given 48 h after injury. At the tenth day, pars plana vitrectomy was done whenever indicated. Flash electroretinogram (ERG) was done before and 3 months post-injection. We assessed ocular inflammation, ERG changes, and retinal layer integrity by optical coherence tomography (OCT). Systemic and vitreous pharmacokinetics were also evaluated.RESULTS: Twelve patients (12 eyes) with perforating globe injuries (zone III) were included and followed for a median of 6 months. Intravitreal decorin injection was well tolerated with no ocular or systemic safety adverse events. Decorin retinal safety was demonstrated anatomically by intact retinal layer by OCT, and functionally by flash ERG which did not show any significant worsening during the study and the final mean logMAR best-corrected visual acuity (BCVA) which was 1.15 (20/280) and 0.7 (20/100) for groups A and B, respectively, and ≥ 20/200 in 75% of all eyes. Decorin serum and vitreous levels were elevated following trauma, with higher and extended levels following intravitreal injection.CONCLUSIONS: No short-term safety concerns were detected after a single intravitreal injection of decorin in patients with perforating injuries.TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02865031.",

author = "Abdullatif, {Abdussalam M} and Macky, {Tamer A} and Abdullatif, {Mona M} and Khaled Nassar and Salvatore Grisanti and Mortada, {Hassan A} and Soliman, {Mahmoud M}",

year = "2018",

doi = "10.1007/s00417-018-4105-7",

language = "English",

volume = "256",

pages = "2473--2481",

journal = "Graefe's Archive for Clinical and Experimental Ophthalmology",

issn = "0721-832X",

number = "12",

}

Intravitreal decorin preventing proliferative vitreoretinopathy in perforating injuries: a pilot study. / Abdullatif, Abdussalam M; Macky, Tamer A; Abdullatif, Mona M et al.
in: Graefe's Archive for Clinical and Experimental Ophthalmology, Jahrgang 256, Nr. 12, 2018, S. 2473-2481.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - Intravitreal decorin preventing proliferative vitreoretinopathy in perforating injuries

T2 - a pilot study

AU - Abdullatif, Abdussalam M

AU - Macky, Tamer A

AU - Abdullatif, Mona M

AU - Nassar, Khaled

AU - Grisanti, Salvatore

AU - Mortada, Hassan A

AU - Soliman, Mahmoud M

PY - 2018

Y1 - 2018

N2 - PURPOSE: To determine the short-term safety of human recombinant decorin protein in preventing proliferative vitreoretinopathy (PVR) in perforating injuries.METHODS: This is a prospective, single-center, open-label, interventional case series. Single intravitreal injection of decorin 200 μg (n = 4) or 400 μg (n = 8) was given 48 h after injury. At the tenth day, pars plana vitrectomy was done whenever indicated. Flash electroretinogram (ERG) was done before and 3 months post-injection. We assessed ocular inflammation, ERG changes, and retinal layer integrity by optical coherence tomography (OCT). Systemic and vitreous pharmacokinetics were also evaluated.RESULTS: Twelve patients (12 eyes) with perforating globe injuries (zone III) were included and followed for a median of 6 months. Intravitreal decorin injection was well tolerated with no ocular or systemic safety adverse events. Decorin retinal safety was demonstrated anatomically by intact retinal layer by OCT, and functionally by flash ERG which did not show any significant worsening during the study and the final mean logMAR best-corrected visual acuity (BCVA) which was 1.15 (20/280) and 0.7 (20/100) for groups A and B, respectively, and ≥ 20/200 in 75% of all eyes. Decorin serum and vitreous levels were elevated following trauma, with higher and extended levels following intravitreal injection.CONCLUSIONS: No short-term safety concerns were detected after a single intravitreal injection of decorin in patients with perforating injuries.TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02865031.

AB - PURPOSE: To determine the short-term safety of human recombinant decorin protein in preventing proliferative vitreoretinopathy (PVR) in perforating injuries.METHODS: This is a prospective, single-center, open-label, interventional case series. Single intravitreal injection of decorin 200 μg (n = 4) or 400 μg (n = 8) was given 48 h after injury. At the tenth day, pars plana vitrectomy was done whenever indicated. Flash electroretinogram (ERG) was done before and 3 months post-injection. We assessed ocular inflammation, ERG changes, and retinal layer integrity by optical coherence tomography (OCT). Systemic and vitreous pharmacokinetics were also evaluated.RESULTS: Twelve patients (12 eyes) with perforating globe injuries (zone III) were included and followed for a median of 6 months. Intravitreal decorin injection was well tolerated with no ocular or systemic safety adverse events. Decorin retinal safety was demonstrated anatomically by intact retinal layer by OCT, and functionally by flash ERG which did not show any significant worsening during the study and the final mean logMAR best-corrected visual acuity (BCVA) which was 1.15 (20/280) and 0.7 (20/100) for groups A and B, respectively, and ≥ 20/200 in 75% of all eyes. Decorin serum and vitreous levels were elevated following trauma, with higher and extended levels following intravitreal injection.CONCLUSIONS: No short-term safety concerns were detected after a single intravitreal injection of decorin in patients with perforating injuries.TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02865031.

U2 - 10.1007/s00417-018-4105-7

DO - 10.1007/s00417-018-4105-7

M3 - Journal articles

C2 - 30128605

SN - 0721-832X

VL - 256

SP - 2473

EP - 2481

JO - Graefe's Archive for Clinical and Experimental Ophthalmology

JF - Graefe's Archive for Clinical and Experimental Ophthalmology

IS - 12

ER -

Intravitreal decorin preventing proliferative vitreoretinopathy in perforating injuries: a pilot study

Abstract

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