Effect of Choline Fenofibrate (SLV348) on Macular Edema

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Placebo; Drug: Choline Fenofibrate

• Registration Number: NCT00683176
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Study Start: 2008-09
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-24
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Choline Fenofibrate	-

Primary Outcome Measures

Name	Time	Method
Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)	12 months

Secondary Outcome Measures

Name	Time	Method
OCT variables (Retinal Thickness, Retinal thickening)	12 months
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
Lipids	12 months
SBP/DBP, Urinary albumin excretion rate	12 months

Trial Locations

Locations (21)

Site Reference ID/Investigator# 54274; 🇩🇰 Glostrup, Denmark

Site Reference ID/Investigator# 54264; 🇪🇸 Santiago de Compostela, Spain

Site Reference ID/Investigator# 54270; 🇨🇿 Usti nad Labem, Czech Republic

Site Reference ID/Investigator# 54271; 🇬🇧 Liverpool, United Kingdom

Site Reference ID/Investigator# 54280; 🇪🇸 Madrid, Spain

Site Reference ID/Investigator# 54275; 🇭🇺 Zalaegerszeg - Pozva, Hungary

Site Reference ID/Investigator# 54272; 🇮🇹 Udine, Italy

Site Reference ID/Investigator# 54268; 🇧🇬 Sofia, Bulgaria

Site Reference ID/Investigator# 54277; 🇭🇺 Gyor, Hungary

Site Reference ID/Investigator# 54269; 🇭🇺 Budapest, Hungary

Site Reference ID/Investigator# 54291; 🇧🇬 Sofia, Bulgaria

Site Reference ID/Investigator# 54267; 🇨🇿 Brno, Czech Republic

Site Reference ID/Investigator# 54282; 🇨🇿 Ostrava-Vitkovice, Czech Republic

Site Reference ID/Investigator# 54279; 🇧🇬 Sofia, Bulgaria

Site Reference ID/Investigator# 54273; 🇧🇬 Sofia, Bulgaria

Site Reference ID/Investigator# 54283; 🇨🇿 Prague, Czech Republic

Site Reference ID/Investigator# 54265; 🇵🇱 Gdansk, Poland

Site Reference ID/Investigator# 54266; 🇵🇱 Katowice, Poland

Site Reference ID/Investigator# 54263; 🇩🇪 Leipzig, Germany

Site Reference ID/Investigator# 54284; 🇩🇪 Muenster, Germany

Site Reference ID/Investigator# 54293; 🇳🇱 Amsterdam, Netherlands