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

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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: 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 Solvay Pharmaceuticals:

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 ]

Estimated Enrollment:	106
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Jean-Claude Ansquer

jean-claude.ansquer@solvay.com

Show 41 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Jean-Claude Ansquer )
Study ID Numbers:	S348.2.001, 2008-001064-37
Study First Received:	May 16, 2008
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00683176 History of Changes
Health Authority:	Austria: Federal Office for Safety in Health Care; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Solvay Pharmaceuticals:

Diabetic Macular Edema
OCT

Additional relevant MeSH terms:

Antimetabolites
Nootropic Agents
Lipotropic Agents
Choline
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Antilipemic Agents
Gastrointestinal Agents
Edema

Macular Degeneration
Retinal Degeneration
Procetofen
Pharmacologic Actions
Macular Edema
Signs and Symptoms
Therapeutic Uses
Central Nervous System Agents
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010