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) - DM2115403

GlaxoSmithKline BV0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

研究概览

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•* 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.

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