Effect of Choline Fenofibrate (SLV348) on Macular Edema

Abbott

Status and phase

Completed

Phase 2

Conditions

Diabetic Macular Edema

Treatments

Drug: Choline Fenofibrate

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00683176

S348.2.001

2008-001064-37 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment

110 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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