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|
|Journal||Graefe's Archive for Clinical and Experimental Ophthalmology|
|Number of pages||9|
|Publication status||Published - 2018|