Randomized Placebo-Controlled Trial Evaluating the Ophthalmic Safety of Single-Dose Tafenoquine in Healthy Volunteers.
Citation: Drug Safety. 42(9):1103-1114, 2019 09.PMID: 31187437Institution: MedStar Harbor HospitalDepartment: PAREXEL Early Phase Clinical UnitForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aminoquinolines/ad [Administration & Dosage] | *Antimalarials/ad [Administration & Dosage] | *Retina/de [Drug Effects] | *Visual Acuity/de [Drug Effects] | Administration, Oral | Adolescent | Adult | Aminoquinolines/ae [Adverse Effects] | Antimalarials/ae [Adverse Effects] | Female | Humans | Male | Middle Aged | Optical Imaging | Prospective Studies | Single-Blind Method | Tomography, Optical Coherence | Young AdultYear: 2019ISSN:- 0114-5916
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | 31187437 | Available | 31187437 |
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).
INTRODUCTION: Tafenoquine has been recently registered for the prevention of relapse in Plasmodium vivax malaria.
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.
OBJECTIVE: This study assessed the pharmacodynamic effects of 300-mg single-dose tafenoquine on the retina.
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.
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