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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Darapladib

Criteria

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