Clinical trial NCT00683176: Effect of Choline Fenofibrate (SLV348) on Macular Edema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema
OCT
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility 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

Primary outcomes:
measure: Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)
timeFrame: 12 months
Secondary outcomes:
measure: OCT variables (Retinal Thickness, Retinal thickening)
timeFrame: 12 months
measure: ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema
timeFrame: 12 months
measure: Lipids
timeFrame: 12 months
measure: SBP/DBP, Urinary albumin excretion rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 54268
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 54291
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 54279
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 54273
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 54267
city: Ostrava-Vitkovice
country: Czech Republic
facility: Site Reference ID/Investigator# 54282
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 54283
city: Usti nad Labem
country: Czech Republic
facility: Site Reference ID/Investigator# 54270
city: Glostrup
country: Denmark
facility: Site Reference ID/Investigator# 54274
city: Leipzig
country: Germany
facility: Site Reference ID/Investigator# 54263
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 54284
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 54269
city: Gyor
country: Hungary
facility: Site Reference ID/Investigator# 54277
city: Zalaegerszeg - Pozva
country: Hungary
facility: Site Reference ID/Investigator# 54275
city: Udine
country: Italy
facility: Site Reference ID/Investigator# 54272
city: Amsterdam
country: Netherlands
facility: Site Reference ID/Investigator# 54293
city: Gdansk
country: Poland
facility: Site Reference ID/Investigator# 54265
city: Katowice
country: Poland
facility: Site Reference ID/Investigator# 54266
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 54280
city: Santiago de Compostela
country: Spain
facility: Site Reference ID/Investigator# 54264
city: Liverpool
country: United Kingdom
facility: Site Reference ID/Investigator# 54271
Study officials:
affiliation: Abbott Products
name: Dr Jean-Claude Ansquer, MD
role: STUDY_DIRECTOR
References: