A Phase 2 interventional study of darapladib and placebo in Retinopathy, Diabetic, sponsored by GlaxoSmithKline. Completed at 16 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-21.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 54 is close to the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
darapladib dosed at 160 mg once daily
Drug: darapladib
Placebo to match once daily
Drug: placebo
Experimental compound 160 mg dose
Placebo to match
Change from baseline in Visual Acuity as measured by ETDRS BCVA
Mean change from baseline in ETDRS Best Corrected Visual Acuity (BCVA) after 3 months of treatment
Time frame: 3 months
Change from baseline in Spectral Domain Optical Coherance Tomography
Mean change from baseline in SD-OCT after 3 months of treatment
Time frame: 3 months
Changes in Retinal Anatomy
Changes in retinal anatomy as assessed by fluorescein angiography and fundus photography and SD-OCT in the study eye
Time frame: 3 months
Safety and Tolerability as assessed by change from baseline in outcome measures
Safety and tolerability as assesed by: change from baseline in blood pressure and heart rate; assessed by change from baseline in complete ophthalmic exam and visual acuity; assessed by change from baseline in clinical laboratory tests; assessed by change from baseline in the collection of adverse events
Time frame: 3 months
Changes in Pharmacodynamic LP-PLA2 enzyme inhibition
Changes over 3 months in the study of LP-PLA2 Enzyme inhibition as data permit
Time frame: 3 months
Peak plasma concentration (Cmax) of study drug
Plasma Pharmacokinetic parameters of darapladib as data permit
Time frame: 3 months
Plasma concentration versus time curve (AUC) of study drug
Plasma Pharmacokinetic parameters of darapladib as data permit
Time frame: 3 months
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline