Effect of Choline Fenofibrate (SLV348) on Macular Edema

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00683176

Enrollment

110

Registered

2008-05-23

Start date

2008-09-30

Completion date

2011-03-31

Last updated

2011-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema, OCT

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)

Interventions

DRUGCholine Fenofibrate

135 mg

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Bulgaria, Czechia, Denmark, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026