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

Autor: Abdullatif AM; Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, El-Manial, Cairo, Egypt. abdussalamabdullatif@kasralainy.edu.eg., Macky TA; Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, El-Manial, Cairo, Egypt., Abdullatif MM; Department of Chemical Pathology, Kasr El Aini Hospital, Cairo University, El-Manial, Cairo, Egypt., Nassar K; Department of Ophthalmology, University of Lübeck, Lübeck, Germany., Grisanti S; Department of Ophthalmology, University of Lübeck, Lübeck, Germany., Mortada HA; Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, El-Manial, Cairo, Egypt., Soliman MM; Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, El-Manial, Cairo, Egypt.
Jazyk: angličtina
Zdroj: Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie [Graefes Arch Clin Exp Ophthalmol] 2018 Dec; Vol. 256 (12), pp. 2473-2481. Date of Electronic Publication: 2018 Aug 20.
DOI: 10.1007/s00417-018-4105-7
Abstrakt: 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.
Databáze: MEDLINE
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