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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
135 mg
Placebo
Site Reference ID/Investigator# 54268
Sofia, Bulgaria
Site Reference ID/Investigator# 54291
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
OCT variables (Retinal Thickness, Retinal thickening)
Time frame: 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
Time frame: 12 months
Lipids
Time frame: 12 months
SBP/DBP, Urinary albumin excretion rate
Time frame: 12 months
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Sofia, Bulgaria
Site Reference ID/Investigator# 54279
Sofia, Bulgaria
Site Reference ID/Investigator# 54273
Sofia, Bulgaria
Site Reference ID/Investigator# 54267
Brno, Czechia
Site Reference ID/Investigator# 54282
Ostrava-Vitkovice, Czechia
Site Reference ID/Investigator# 54283
Prague, Czechia
Site Reference ID/Investigator# 54270
Ústí nad Labem, Czechia
Site Reference ID/Investigator# 54274
Glostrup Municipality, Denmark
Site Reference ID/Investigator# 54263
Leipzig, Germany
...and 11 more locations