Effect of Choline Fenofibrate (SLV348) on Macular Edema

Condition(s) targeted: Diabetic Macular Edema

Intervention: Choline Fenofibrate (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

Overall contact:
Jean-Claude Ansquer, Email: jean-claude.ansquer@solvay.com

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)

Official title: Effect of Choline Fenofibrate (SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects With Diabetic Macular Edema - a One-year, Placebo-Controlled, Randomized Study

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)

Secondary outcome:

OCT variables (Retinal Thickness, Retinal thickening)

ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema

Lipids

SBP/DBP, Urinary albumin excretion rate

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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

Jean-Claude Ansquer, Email: jean-claude.ansquer@solvay.com

Site 11, Innsbruck, Austria; Terminated

Site 12, Sofia, Bulgaria; Recruiting

Site 13, Sofia, Bulgaria; Recruiting

Site 46, Sofia, Bulgaria; Not yet recruiting

Site 14, Usti Nad Labem, Czech Republic; Recruiting

Site 15, Brno, Czech Republic; Recruiting

Site 47, Prague, Czech Republic; Recruiting

Site 48, Ostrava, Czech Republic; Not yet recruiting

Site 49, Prague, Czech Republic; Not yet recruiting

Site 16, Arhus, Denmark; Recruiting

Site 17, Glostrup, Denmark; Recruiting

Site 18, Odense, Denmark; Terminated

Site 19, Paris, France; Recruiting

Site 20, Bobigny, France; Withdrawn

Site 21, Paris, France; Recruiting

Site 22, Paris, France; Not yet recruiting

Site 23, Tuebingen, Germany; Withdrawn

Site 24, Bonn, Germany; Withdrawn

Site 25, Munster, Germany; Recruiting

Site 26, Aachen, Germany; Withdrawn

Site 27, Leipzig, Germany; Recruiting

Site 28, Gyor, Hungary; Recruiting

Site 29, Budapest, Hungary; Recruiting

Site 30, Zalaegerszeg-Pozva, Hungary; Recruiting

Site 31, Udine, Italy; Recruiting

Site 32, Milano, Italy; Withdrawn

Site 40, Rotterdam, Netherlands; Withdrawn

Site 41, Amsterdam, Netherlands; Recruiting

Site 33, Poznan, Poland; Withdrawn

Site 34, Lodz, Poland; Recruiting

Site 35, Gdansk, Poland; Recruiting

Site 36, Katowice, Poland; Recruiting

Site 37, Valencia, Spain; Recruiting

Site 38, La Coruna, Spain; Recruiting

Site 39, Madrid, Spain; Recruiting

Site 42, Birmingham, United Kingdom; Withdrawn

Site 43, Bradford, United Kingdom; Recruiting

Site 44, Edinburgh, United Kingdom; Not yet recruiting

Site 45, Liverpool, United Kingdom; Recruiting

Starting date: September 2008
Ending date: March 2011
Last updated: September 24, 2009