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

PurposeTo determine the short-term safety of human recombinant decorin protein in preventing proliferative vitreoretinopathy (PVR) in perforating injuries.MethodsThis is a prospective, single-center, open-label, interventional case series. Single intravitreal injection of decorin 200g (n=4) or 400g (n=8) was given 48h after injury. At the tenth day, pars plana vitrectomy was done whenever indicated. Flash electroretinogram (ERG) was done before and 3months post-injection. We assessed ocular inflammation, ERG changes, and retinal layer integrity by optical coherence tomography (OCT). Systemic and vitreous pharmacokinetics were also evaluated.ResultsTwelve patients (12 eyes) with perforating globe injuries (zone III) were included and followed for a median of 6months. 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.ConclusionsNo short-term safety concerns were detected after a single intravitreal injection of decorin in patients with perforating injuries.Trial registrationClinicalTrials.gov ID: NCT02865031