Effect of Choline Fenofibrate (SLV348) on Macular Edema

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

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)

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Placebo; Drug: Choline Fenofibrate

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1000
    • Site Reference ID/Investigator# 54268
  • Sofia, Bulgaria, 1233
    • Site Reference ID/Investigator# 54291
  • Sofia, Bulgaria, 1408
    • Site Reference ID/Investigator# 54279
  • Sofia, Bulgaria, 1517
    • Site Reference ID/Investigator# 54273
• Czech Republic
  • Brno, Czech Republic, 62500
    • Site Reference ID/Investigator# 54267
  • Ostrava-Vitkovice, Czech Republic, 703 84
    • Site Reference ID/Investigator# 54282
  • Prague, Czech Republic, 169 02
    • Site Reference ID/Investigator# 54283
  • Usti nad Labem, Czech Republic, 40113
    • Site Reference ID/Investigator# 54270
• Denmark
  • Glostrup, Denmark, 2600
    • Site Reference ID/Investigator# 54274
• Germany
  • Leipzig, Germany, 04103
    • Site Reference ID/Investigator# 54263
  • Muenster, Germany, 48145
    • Site Reference ID/Investigator# 54284
• Hungary
  • Budapest, Hungary, 1106
    • Site Reference ID/Investigator# 54269
  • Gyor, Hungary, H-9023
    • Site Reference ID/Investigator# 54277
  • Zalaegerszeg - Pozva, Hungary, 8900
    • Site Reference ID/Investigator# 54275
• Italy
  • Udine, Italy, 33100
    • Site Reference ID/Investigator# 54272
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Site Reference ID/Investigator# 54293
• Poland
  • Gdansk, Poland, 80-147
    • Site Reference ID/Investigator# 54265
  • Katowice, Poland, 40-760
    • Site Reference ID/Investigator# 54266
• Spain
  • Madrid, Spain, 28002
    • Site Reference ID/Investigator# 54280
  • Santiago de Compostela, Spain, 15705
    • Site Reference ID/Investigator# 54264
• United Kingdom
  • Liverpool, United Kingdom, L7 8XP
    • Site Reference ID/Investigator# 54271

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Drug: Placebo; Placebo
Active Comparator: 1	Drug: Choline Fenofibrate; 135 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
OCT variables (Retinal Thickness, Retinal thickening)	12 months
ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema	12 months
Lipids	12 months
SBP/DBP, Urinary albumin excretion rate	12 months

Collaborators and Investigators

• Sponsor: Abbott Products
• Investigators: Study Director: Dr Jean-Claude Ansquer, MD, Abbott Products

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: May 16, 2008
• First Submitted That Met QC Criteria: May 22, 2008
• First Posted (Estimate): May 23, 2008

Study Record Updates

• Last Update Posted (Estimate): August 26, 2011
• Last Update Submitted That Met QC Criteria: August 24, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: OCT; Diabetic Macular Edema
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline; Fenofibrate
• Other Study ID Numbers: S348.2.001; 2008-001064-37 (EudraCT Number)