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

NCT01506895 | Completed Phase 2

• 1 other identifier: 115403
• Study Type: interventional
• Target: 54
• Locations: 5 countries
• Sites: 16

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.

Conditions

Retinopathy, Diabetic

Keywords

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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

  3 months

• Change from baseline in Spectral Domain Optical Coherance Tomography

  Mean change from baseline in SD-OCT after 3 months of treatment

  3 months

Secondary Outcomes (5)

• Changes in Retinal Anatomy

  3 months

• Safety and Tolerability as assessed by change from baseline in outcome measures

  3 months

• Changes in Pharmacodynamic LP-PLA2 enzyme inhibition

  3 months

• Peak plasma concentration (Cmax) of study drug

  3 months

• Plasma concentration versus time curve (AUC) of study drug

  3 months

Study Arms (2)

darapladib

EXPERIMENTAL

darapladib dosed at 160 mg once daily

Drug: darapladib

placebo

PLACEBO COMPARATOR

Placebo to match once daily

Drug: placebo

Interventions

darapladib DRUG

Experimental compound 160 mg dose

darapladib

placebo DRUG

Placebo to match

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (16)

GSK Investigational Site

Parramatta, New South Wales, 2150, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2000, Australia

Location

GSK Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

GSK Investigational Site

Glostrup Municipality, Denmark

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

GSK Investigational Site

Ulm, Baden-Wurttemberg, 89075, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 51109, Germany

Location

GSK Investigational Site

Münster, North Rhine-Westphalia, 48145, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Milan, Lombardy, 20132, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20157, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10122, Italy

Location

GSK Investigational Site

Padua, Veneto, 35128, Italy

Location

GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

GSK Investigational Site

Rotterdam, 3011 BH, Netherlands

Location

Related Links

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

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

darapladib

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: January 10, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 21, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (5); AU (4); DK (1); IT (4); NL (2)