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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01506895
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):

December 21, 2011
January 10, 2012
November 21, 2016
February 2012
February 2013   (Final data collection date for primary outcome measure)
  • Change from baseline in Visual Acuity as measured by ETDRS BCVA [ Time Frame: 3 months ]
    Mean change from baseline in ETDRS Best Corrected Visual Acuity (BCVA) after 3 months of treatment
  • Change from baseline in Spectral Domain Optical Coherance Tomography [ Time Frame: 3 months ]
    Mean change from baseline in SD-OCT after 3 months of treatment
Same as current
Complete list of historical versions of study NCT01506895 on ClinicalTrials.gov Archive Site
  • Changes in Retinal Anatomy [ Time Frame: 3 months ]
    Changes in retinal anatomy as assessed by fluorescein angiography and fundus photography and SD-OCT in the study eye
  • Safety and Tolerability as assessed by change from baseline in outcome measures [ Time Frame: 3 months ]
    Safety and tolerability as assesed by: change from baseline in blood pressure and heart rate; assessed by change from baseline in complete ophthalmic exam and visual acuity; assessed by change from baseline in clinical laboratory tests; assessed by change from baseline in the collection of adverse events
  • Changes in Pharmacodynamic LP-PLA2 enzyme inhibition [ Time Frame: 3 months ]
    Changes over 3 months in the study of LP-PLA2 Enzyme inhibition as data permit
  • Peak plasma concentration (Cmax) of study drug [ Time Frame: 3 months ]
    Plasma Pharmacokinetic parameters of darapladib as data permit
  • Plasma concentration versus time curve (AUC) of study drug [ Time Frame: 3 months ]
    Plasma Pharmacokinetic parameters of darapladib as data permit
  • Changes in Retinal Anatomy [ Time Frame: 3 months ]
    Changes in retinal anatomy as assessed by fluorescein angiography and fundus photography and SD-OCT in the study eye
  • Safety and Tolerability as assessed by change from baseline in blood pressure and heart rate [ Time Frame: 3 months ]
    Safety and tolerability assessed by complete ophthalmic examination, visual acuity, vital sign measures, clinical laboratory tests, clinical monitoring and adverse event reporting
  • Changes in Pharmacodynamic LP-PLA2 enzyme inhibition [ Time Frame: 3 months ]
    Changes over 3 months in the study of LP-PLA2 Enzyme inhibition as data permit
  • Safety and Tolerability as assessed by change from baseline in complete ophthalmic examination and visual acuity [ Time Frame: 3 months ]
    Safety and tolerability assessed by complete ophthalmic examination, visual acuity, vital sign measures, clinical laboratory tests, clinical monitoring and adverse event reporting
  • Safety and Tolerability as assessed by change from baseline in clinical laboratory tests [ Time Frame: 3 months ]
    Safety and tolerability assessed by complete ophthalmic examination, visual acuity, vital sign measures, clinical laboratory tests, clinical monitoring and adverse event reporting
  • Safety and Tolerability as assessed by change from baseline in the collection of adverse events [ Time Frame: 3 months ]
    Safety and tolerability assessed by complete ophthalmic examination, visual acuity, vital sign measures, clinical laboratory tests, clinical monitoring and adverse event reporting
  • Peak plasma concentration (Cmax) of study drug [ Time Frame: 3 months ]
    Plasma Pharmacokinetic parameters of darapladib as data permit
  • Plasma concentration versus time curve (AUC) of study drug [ Time Frame: 3 months ]
    Plasma Pharmacokinetic parameters of darapladib as data permit
Not Provided
Not Provided
 
A Phase 2 Clinical Study to Investigate Effects of Darapladib in Subjects With Diabetic Macular Edema
A Phase 2, Multi-national, Multi-centre, Double Masked, Randomised, Placebo Controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Darapladib Administered for 3 Months to Adult Subjects With Diabetic Macular Edema With Centre Involvement
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Retinopathy, Diabetic
  • Drug: darapladib
    Experimental compound 160 mg dose
  • Drug: placebo
    Placebo to match
  • Experimental: darapladib
    darapladib dosed at 160 mg once daily
    Intervention: Drug: darapladib
  • Placebo Comparator: placebo
    Placebo to match once daily
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Denmark,   Germany,   Italy,   Netherlands
 
 
NCT01506895
115403
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP