Effect of Choline Fenofibrate (SLV348) on Macular Edema

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of choline fenofibrate on the regression of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with diabetic macular edema (DME)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott Products
• Treatments: Choline; Fenofibrate

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