Effect of Choline Fenofibrate (SLV348) on Macular Edema
This study has been completed.
Sponsor:
Abbott Products
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT00683176
First received: May 16, 2008
Last updated: August 24, 2011
Last verified: August 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| 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
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 May 19, 2013