Effect of Choline Fenofibrate (SLV348) on Macular Edema

Launched by ABBOTT PRODUCTS · May 22, 2008

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • With DME in at least one eye of the subject and this eye presenting with macula thickness ≥ 300 µm on OCT examination at baseline in at least one of the 5 following zones: center zone, or superior inner zone, or nasal inner zone, or inferior inner zone, or temporal inner zone, confirmed after central reading of the OCT;
• • When laser treatment can be safely postponed by up to at least 3 months;
• • With established T2DM and HbA1c \< 10%;
• • With systolic blood pressure (SBP) or diastolic blood pressure (DBP) \< 160/90 mmHg;
• • With documented elevated triglyceride levels (TG \>=150 mg/dL \[1.70 mmol/L\]) at the screening visit or in the previous 3 months.
• • Exclusion Criteria
• • Previous laser photocoagulation;
• • Eye retinal thickening results from epiretinal membranes or vitreomacular traction; glaucoma;
• • Poor visual acuity: visual acuity of 20/800