Effect of Choline Fenofibrate (SLV348) on Macular Edema

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683176
• Other study ID #: S348.2.001
• Secondary ID: 2008-001064-37
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2008
• Last updated: August 24, 2011
• Start date: September 2008
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlBulgaria: Bulgarian Drug AgencyHungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: Ministry of Health, Welfare and SportAustria: Federal Office for Safety in Health CareSpain: Agencia Española de Medicamentos y Productos SanitariosDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Choline Fenofibrate
135 mg
• Placebo
Placebo

Locations

Country	Name	City	State
Bulgaria	Site Reference ID/Investigator# 54268	Sofia
Bulgaria	Site Reference ID/Investigator# 54273	Sofia
Bulgaria	Site Reference ID/Investigator# 54279	Sofia
Bulgaria	Site Reference ID/Investigator# 54291	Sofia
Czech Republic	Site Reference ID/Investigator# 54267	Brno
Czech Republic	Site Reference ID/Investigator# 54282	Ostrava-Vitkovice
Czech Republic	Site Reference ID/Investigator# 54283	Prague
Czech Republic	Site Reference ID/Investigator# 54270	Usti nad Labem
Denmark	Site Reference ID/Investigator# 54274	Glostrup
Germany	Site Reference ID/Investigator# 54263	Leipzig
Germany	Site Reference ID/Investigator# 54284	Muenster
Hungary	Site Reference ID/Investigator# 54269	Budapest
Hungary	Site Reference ID/Investigator# 54277	Gyor
Hungary	Site Reference ID/Investigator# 54275	Zalaegerszeg - Pozva
Italy	Site Reference ID/Investigator# 54272	Udine
Netherlands	Site Reference ID/Investigator# 54293	Amsterdam
Poland	Site Reference ID/Investigator# 54265	Gdansk
Poland	Site Reference ID/Investigator# 54266	Katowice
Spain	Site Reference ID/Investigator# 54280	Madrid
Spain	Site Reference ID/Investigator# 54264	Santiago de Compostela
United Kingdom	Site Reference ID/Investigator# 54271	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Products

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Denmark,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)		12 months	No
Secondary	OCT variables (Retinal Thickness, Retinal thickening)		12 months	No
Secondary	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	No
Secondary	Lipids		12 months	No
Secondary	SBP/DBP, Urinary albumin excretion rate		12 months	Yes