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

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

Clinic of Ophtalmology

Cairo University

23 Citations (Scopus)

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.

Translated title of the contribution	Intravitreales Decorin verhindert proliferative Vitreoretinopathie bei perforierenden Verletzungen: eine Pilot Studie
Original language	English
Journal	Graefe's Archive for Clinical and Experimental Ophthalmology
Volume	256
Issue number	12
Pages (from-to)	2473-2481
Number of pages	9
ISSN	0721-832X
DOIs	https://doi.org/10.1007/s00417-018-4105-7
Publication status	Published - 2018

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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",

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pages = "2473--2481",

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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

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