A 3 month Study of Darapladib to Treat Diabetic Macular Edema (DME).

Conditions: Diabetic macular edema with centre involvement
MedDRA version: 14.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2011-002944-28-IT

Lead Sponsor: GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1) Subject is at least 18 years of age inclusive. 2) A female subject is eligible if she is of non-childbearing potential or if she agrees to use one of the approved contraception methods for an appropriate period of time. 3) Diagnosis of diabetes mellitus (type 1 or type 2). 4) Confirmation of DME in the study eye by investigator-determined fluorescein angiography. 5) Retinal thickening (diabetic macular edema) involving the centre of the fovea in the study eye as defined by investigator-determined SD-OCT central subfield thickness > 330 microns (Heidelberg Spectralis) and >310 (Zeiss Cirrus); if both eyes are eligible, the eye with the greater OCT centre subfield score is selected as the study eye.6) Best corrected visual acuity score of 78-24 letters in the study eye.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1) Additional eye disease in the study eye that could compromise assessment of BCVA or imaging of the posterior pole by fundus photography, fluorescein angiography, or spectral domain OCT, or is likely to require intervention during the ~4 months study. 2) Active proliferative diabetic retinopathy in the study eye. 3)Ischemic maculopathy on fluorescein angiography defined as a total area of capillary loss greater than 2 disc areas (> 5mm2) within the ETDRS macular grid or a foveal avascular zone greatest linear diameter of > 1000 microns. 4) History of choroidal neovascularization in the study eye, or current choroidal neovascularization in the fellow eye requiring treatment. 5)Intraocular surgery in the study eye within 3 months of dosing. 6) Laser photocoagulation in the study eye within 3 months of dosing. 7) Use of intravitreal ranibizumab in the study eye within 90 days of dosing. 8) Use of intravitreal bevacizumab in the study eye within 180 days of dosing. 9)Use of intraocular steroids in the study eye within 180 days of dosing. 10) Use of intravitreal bevacizumab in the fellow eye or expected need for intravitreal bevacizumab in the fellow eye during the course of the study. 11) Best corrected visual acuity score by electronic ETDRS < 56 letters in the fellow eye at screening. 12) Use of any systemically administered anti-angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib) within 6 months of dosing. 13) Evidence of vitreomacular traction as determined by the Investigator. 14) Uncontrolled intraocular pressure >22 mmHg in the study eye despite treatment with glaucoma medication. 15) Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol). 16) Uncontrolled diabetes as indicated by HbA1c >10% at screening. 17) Evidence of clinical instability or abnormal clinical laboratory findings prior to randomisation that, in the opinion of the Investigator, makes the subject unsuitable for the study. 18) Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones) or evidence of abnormal liver function tests. 19) Severe renal impairment. 20) Poorly controlled hypertension despite lifestyle modifications and pharmacotherapy. 21) Current severe heart failure (New York Heart Association class III or IV). 22) QTcF > 480msec in any subject including those with Bundle Branch Block. 23) Severe asthma that is poorly controlled on pharmacotherapy. 24) History of anaphylaxis, anaphylactoid reactions, or severe allergic responses.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of darapladib administered as oral daily doses for 3 months on best-corrected visual acuity (BCVA) and spectral domain OCT (SD-OCT) centre subfield of the study eye in adult subjects with centre-involved DME.;Secondary Objective: • To determine the effect of darapladib administered as oral daily doses for 3 months on retina anatomy of the study eye in adult subjects with centre-involved DME • To assess safety and tolerability of darapladib in adult subjects with centre-involved DME • To determine the pharmacokinetic and pharmacodynamic profiles of darapladib in adult subjects with centre-involved DME, as data permit;Primary end point(s): Mean change from baseline in ETDRS Best Corrected Visual Acuity (BCVA) and SD-OCT centre subfield retinal thickness in the study eye.;Timepoint(s) of evaluation of this end point: 3 MONTHS

Secondary Outcome Measures