Effect of Choline Fenofibrate (SLV348) on Macular Edema - Full Text View

Sponsor:	Abbott Products
Information provided by (Responsible Party):	Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:	NCT00683176

Purpose

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	Intervention	Phase
Diabetic Macular Edema	Drug: Choline Fenofibrate Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Choline Choline chloride Procetofen Choline dihydrogen citrate Choline bitartrate Choline fenofibrate Choline salicylate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

OCT variables (Retinal Thickness, Retinal thickening) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Lipids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
SBP/DBP, Urinary albumin excretion rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	110
Study Start Date:	September 2008
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Choline Fenofibrate 135 mg
Placebo Comparator: 2	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683176

Locations

Bulgaria
Site Reference ID/Investigator# 54268
Sofia, Bulgaria, 1000
Site Reference ID/Investigator# 54273
Sofia, Bulgaria, 1517
Site Reference ID/Investigator# 54279
Sofia, Bulgaria, 1408
Site Reference ID/Investigator# 54291
Sofia, Bulgaria, 1233
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
Denmark
Site Reference ID/Investigator# 54274
Glostrup, Denmark, 2600
Germany
Site Reference ID/Investigator# 54263
Leipzig, Germany, 04103
Site Reference ID/Investigator# 54284
Muenster, Germany, 48145
Hungary
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
Italy
Site Reference ID/Investigator# 54272
Udine, Italy, 33100
Netherlands
Site Reference ID/Investigator# 54293
Amsterdam, Netherlands, 1105 AZ
Poland
Site Reference ID/Investigator# 54265
Gdansk, Poland, 80-147
Site Reference ID/Investigator# 54266
Katowice, Poland, 40-760
Spain
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

Investigators

Study Director:

Dr Jean-Claude Ansquer, MD

Abbott Products

More Information

No publications provided

Responsible Party:	Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:	NCT00683176 History of Changes
Other Study ID Numbers:	S348.2.001, 2008-001064-37
Study First Received:	May 16, 2008
Last Updated:	August 24, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Bulgaria: Bulgarian Drug Agency; Hungary: National Institute of Pharmacy; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: Ministry of Health, Welfare and Sport; Austria: Federal Office for Safety in Health Care; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Abbott:

Diabetic Macular Edema
OCT

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choline
Fenofibrate
Lipotropic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012