Effect of Choline Fenofibrate (SLV348) on Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00683176
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : August 26, 2011
Information provided by (Responsible Party):
Abbott ( Abbott Products )

Brief 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)

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Choline Fenofibrate Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: Choline Fenofibrate
135 mg
Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment) [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00683176

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

Responsible Party: Abbott Products Identifier: NCT00683176     History of Changes
Other Study ID Numbers: S348.2.001
2008-001064-37 ( EudraCT Number )
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Abbott ( Abbott Products ):
Diabetic Macular Edema

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Lipotropic Agents
Gastrointestinal Agents
Nootropic Agents