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

NCT ID: NCT01506895

Last Updated: 2016-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-02-28

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 darapladib in diabetic macular edema patients with centre involvement.

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 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.

Conditions

Retinopathy, Diabetic

Keywords

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

darapladib

darapladib dosed at 160 mg once daily

Group Type: EXPERIMENTAL

darapladib

Intervention Type: DRUG

Experimental compound 160 mg dose

placebo

Placebo to match once daily

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo to match

Interventions

darapladib

Experimental compound 160 mg dose

Intervention Type: DRUG

placebo

Placebo to match

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Parramatta, New South Wales, Australia

GSK Investigational Site

Sydney, New South Wales, Australia

GSK Investigational Site

East Melbourne, Victoria, Australia

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Glostrup Municipality, , Denmark

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Turin, Piedmont, Italy

GSK Investigational Site

Padua, Veneto, Italy

GSK Investigational Site

Amsterdam, , Netherlands

GSK Investigational Site

Rotterdam, , Netherlands

Countries

Australia; Denmark; Germany; Italy; Netherlands

Study Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Study Protocol

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Dataset Specification

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

115403

Identifier Type: -

Identifier Source: org_study_id