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

Autor: Tamer A. Macky, Mona Abdullatif, Abdussalam M Abdullatif, Khaled Nassar, Salvatore Grisanti, Hassan Aly Mortada, Mahmoud Soliman
Rok vydání: 2018
Předmět:
0301 basic medicine
Male
Proliferative vitreoretinopathy
Visual acuity
genetic structures
Decorin
medicine.medical_treatment
Visual Acuity
Vitrectomy
Pilot Projects
chemistry.chemical_compound
0302 clinical medicine
Prospective Studies
Sensory Systems
medicine.anatomical_structure
Treatment Outcome
Intravitreal Injections
Female
medicine.symptom
Erg
Tomography
Optical Coherence
Pars plana
Adult
medicine.medical_specialty
Adolescent
Retina
03 medical and health sciences
Cellular and Molecular Neuroscience
Young Adult
Ophthalmology
medicine
Electroretinography
Humans
Adverse effect
Dose-Response Relationship
Drug
business.industry
Vitreoretinopathy
Proliferative
Retinal
medicine.disease
eye diseases
Eye Injuries
Penetrating
Vitreous Body
030104 developmental biology
chemistry
030221 ophthalmology & optometry
sense organs
business
Follow-Up Studies
Zdroj: Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 256(12)
ISSN: 1435-702X
Popis: To determine the short-term safety of human recombinant decorin protein in preventing proliferative vitreoretinopathy (PVR) in perforating injuries. 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. 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. No short-term safety concerns were detected after a single intravitreal injection of decorin in patients with perforating injuries. ClinicalTrials.gov ID: NCT02865031
Databáze: OpenAIRE
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