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 (DM2115403)
- Conditions
- macular edema10015917
- Registration Number
- NL-OMON35596
- Lead Sponsor
- GlaxoSmithKline BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
* Male and female patients 18 years or above with diabetic macular edema and central involvement.
* Confirmation of diagnosis in the study eye by fluorescein angiography.
* Retinal thickening > 330 microns for Heidelberg Spectralis and >310 for Zeiss Cirrus.
* Best corrected visual acuity score of 78-24 letters (Snellen equivalent ~20/32 to 20/320).
* Diabetes mellitus type 1 or 2.
* Safe contraception for women of childbearing potential.
* Additional eye disease in the study eye that could compromise assessments.
* Active proliferative diabetic retinopathy in the study eye.
* Ischemic maculopathy (see protocol for details).
* History of choroidal neovascularization in the study eye, or current choroidal neovascularization in the fellow eye requiring treatment.
* Intraocular surgery or laser photocoagulation in the study eye within 3 months of dosing.
* Study eye: intravitreal ranibizumab within 90 days or or intraocular steroids within 180 days of dosing.
* Fellow eye: (expected need for) intravitreal bevacizumab during the study.
* Best-corrected visual acuity score by electronic ETDRS < 56 letters in the fellow eye at screening.
* Use of any systemically administered anti-angiogenic agent within 6 months of dosing.
* Uncontrolled intraocular pressure >22 mmHg in the study eye despite treatment.
* Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina.
* HbA1c >10% at screening.
* Severe asthma that is poorly controlled.
* Chronic administration of strong CYP3A4 inhibitors.
* History of or current chronic use of systemic steroids 30 days or less prior to screening.
* Breastfeeding, pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Best Corrected Visual Acuity and SD-OCT2 centre subfield retinal thickness in<br /><br>the study eye.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Changes in retinal anatomy of the study eye, safety and tolerability, PK, PD.</p><br>