A Phase 2 Clinical Study to Investigate Effects of Darapladib in Subjects With Diabetic Macular Edema

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Retinopathy, Diabetic

Treatments

Drug: placebo

Drug: darapladib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01506895

115403

Details and patient eligibility

About

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.

Full description

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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A female subject is eligible to participate if she is of: Non-childbearing potential or child-bearing potential and agrees to contraception for an appropriate period of time
Diagnosis of diabetes mellitus (type 1 or type 2)
Confirmation of DME in the study eye by angiography
Confirmation of retinal thickening in the study eye by study doctor
Best corrected visual acuity score of 78-24 letters in the study eye

Exclusion criteria

Additional eye disease in the study eye that could compromise study assessments
Intraocular surgery, or laser photocoagulation in the study eye within 3 months of dosing
Uncontrolled intraocular pressure in the study eye despite treatment with glaucoma medication
Uncontrolled diabetes
Certain types of liver disease
Severe reduction in kidney function OR removal of a kidney OR kidney transplant
Blood pressure higher than normal despite lifestyle changes and treatment with medications
Certain medications that may interfere with the study medication or eye assessments (these will be identified by the study doctor)
Current severe heart failure
Severe asthma that is poorly controlled with medication
Previous severe allergic reaction to food, medications, drink, insect stings, etc
If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded
Recent participation in a study of an investigational medication
Any other reason the investigator deems the subject should not participate in the study
Other protocol-defined inclusion/exclusion criteria may apply