Status:
COMPLETED
A Phase 2 Clinical Study to Investigate Effects of Darapladib in Subjects With Diabetic Macular Edema
Lead Sponsor:
GlaxoSmithKline
Conditions:
Retinopathy, Diabetic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 d...
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01506895
Start Date
February 1 2012
End Date
February 1 2013
Last Update
November 21 2016
Active Locations (16)
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1
GSK Investigational Site
Parramatta, New South Wales, Australia, 2150
2
GSK Investigational Site
Sydney, New South Wales, Australia, 2000
3
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
4
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009