Assessment of Any Potential Retinal Effects of Tafenoquine (TQ)
Status:
Completed
Trial end date:
2017-09-14
Target enrollment:
Participant gender:
Summary
The study aims to provide evidence of retinal safety to support the use of tafenoquine as a
potential single dose radical cure treatment for patients with Plasmodium vivax (P. vivax)
malaria (i.e., co-administration of a schizonticidal drug with TQ). The study will be
conducted as a single masked, randomized, placebo-controlled, parallel group design. It will
assess retinal changes from baseline using spectral domain optical coherence tomography (OCT)
and fundus auto fluorescence (FAF) at Month 3 (90 days) post-dose in adult healthy volunteers
(participants). A placebo control group will be used to compare the results in the TQ group.
Interim analysis will be conducted after completing 100 out of 300 participants in TQ group
and 50 out of 150 participants in matched placebo.