Retinopathy, Diabetic Clinical Trial
Official title:
A Phase 2, Multi-national, Multi-centre, Double Masked, Randomised, Placebo Controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Darapladib Administered for 3 Months to Adult Subjects With Diabetic Macular Edema With Centre Involvement
The purpose of this study is to characterize the systemic and ocular safety and tolerability, pharmacokinetics, exploratory efficacy and pharmacodynamics of 3 months of repeat administration of oral darapladib in diabetic macular edema patients with centre involvement.
This is a multi-national, multi-centre, randomised, double-masked, placebo-controlled,
parallel-group study of repeat oral administration of 160 mg darapladib for 3 months in adult
subjects with DME with centre involvement.
Eligible subjects will be randomised in a 2:1 ratio of active treatment to placebo, with the
placebo group to allow a comparison of safety between treatment arms and to minimize the open
label effect that can be observed with the visual acuity endpoint.
The primary aim of the study is to determine the effect of repeat doses of darapladib on the
mean change from baseline of both best-corrected visual acuity (BCVA) and spectral domain OCT
(SD-OCT) centre subfield. The study eye will be examined for changes over the life of the
study. As this investigational treatment is systemic, the fellow eye may be examined in
tandem to provide additional data.
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