Status:
COMPLETED
Effect of Choline Fenofibrate (SLV348) on Macular Edema
Lead Sponsor:
Abbott Products
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00683176
Start Date
September 1 2008
End Date
March 1 2011
Last Update
August 26 2011
Active Locations (21)
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1
Site Reference ID/Investigator# 54268
Sofia, Bulgaria, 1000
2
Site Reference ID/Investigator# 54291
Sofia, Bulgaria, 1233
3
Site Reference ID/Investigator# 54279
Sofia, Bulgaria, 1408
4
Site Reference ID/Investigator# 54273
Sofia, Bulgaria, 1517