Citation: ; Drug Safety. 42(9):1103-1114, 2019 09..Journal: Drug safety.Published: ; 2019; ISSN: 0114-5916.Full author list: Ackert J; Baranano DE; Berni A; Coleman H; Duparc S; El-Harazi S; Gevorkyan H; Green JA; Hardaker E; Hussaini A; Jones SW; Kelly DS; Koh GCKW; Mohamed K; Patel J; Rasmussen S; Sergott RC; Slakter JS; Thompson JT; Tonkyn J; Warren KA; Wolstenholme A; Yuan A.UI/PMID: 31187437.Subject(s): Administration, Oral | Young Adult | *Visual Acuity/de [Drug Effects] | Tomography, Optical Coherence | Single-Blind Method | *Retina/de [Drug Effects] | Prospective Studies | Optical Imaging | Middle Aged | Male | Humans | Female | Antimalarials/ae [Adverse Effects] | *Antimalarials/ad [Administration & Dosage] | Aminoquinolines/ae [Adverse Effects] | *Aminoquinolines/ad [Administration & Dosage] | Adult | AdolescentInstitution(s): MedStar Harbor HospitalDepartment(s): PAREXEL Early Phase Clinical UnitActivity type: Journal Article.Medline article type(s): Journal ArticleDigital Object Identifier: https://dx.doi.org/10.1007/s40264-019-00839-w (Click here)Abbreviated citation: ; Drug Saf. 42(9):1103-1114, 2019 09.Abstract: CONCLUSION: There was no evidence of any pharmacodynamic effect of 300-mg single-dose tafenoquine on the retina or any short-term clinically relevant effects on ophthalmic safety. This clinical trial is registered with ClinicalTrials.gov (identifier: NCT02658435).Abstract: INTRODUCTION: Tafenoquine has been recently registered for the prevention of relapse in Plasmodium vivax malaria.Abstract: METHODS: This phase I, prospective, multicenter, randomized, single-masked, placebo-controlled, parallel-group study was conducted between 2 February 2016 and 14 September 2017 at three US study centers. Adult healthy volunteers were randomized (2:1) to receive either a single 300-mg oral dose of tafenoquine or matched placebo on day 1. Ophthalmic assessments, including spectral domain optical coherence tomography (SD-OCT) and fundus autofluorescence (FAF), were conducted at baseline and day 90 and evaluated for pre-determined endpoints by an independent, masked reading center.Abstract: OBJECTIVE: This study assessed the pharmacodynamic effects of 300-mg single-dose tafenoquine on the retina.Abstract: RESULTS: One subject in each group met the composite primary endpoint for retinal changes identified with SD-OCT or FAF, i.e., one out of 306 (0.3%) with tafenoquine, one out of 161 (0.6%) with placebo. Both cases had unilateral focal ellipsoid zone disruption at day 90 with no effect on best-corrected visual acuity. The tafenoquine-treated subject had this abnormality at baseline, and was enrolled in error. There was no difference in ophthalmic safety between tafenoquine and placebo.