| May 16, 2008 |
| October 22, 2009 |
| September 2008 |
| March 2011 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00683176 on ClinicalTrials.gov Archive Site |
- OCT variables (Retinal Thickness, Retinal thickening) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Lipids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- SBP/DBP, Urinary albumin excretion rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| 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 |
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) |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Diabetic Macular Edema |
- Drug: Choline Fenofibrate
- Drug: Placebo
|
| |
| |
| |
| Recruiting |
| 106 |
| March 2011 |
| March 2011 (final data collection date for primary outcome measure) |
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
|
| Both |
| 30 Years and older |
| No |
|
|
| Austria, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom |
| |
| NCT00683176 |
| Jean-Claude Ansquer, Solvay Pharmaceuticals |
| S348.2.001, 2008-001064-37 |
| Solvay Pharmaceuticals |
|
| Study Director: |
Global Clinical Director Solvay |
Solvay Pharmaceuticals |
|
|
| Solvay Pharmaceuticals |
| October 2009 |
