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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001064-37 | EudraCT Number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choline Fenofibrate | Drug | 135 mg |
| |
| Placebo |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dr Jean-Claude Ansquer, MD | Abbott Products | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 54268 | Sofia | 1000 | Bulgaria | |||
| Site Reference ID/Investigator# 54291 |
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| Drug |
Placebo |
|
| Lipids | 12 months |
| SBP/DBP, Urinary albumin excretion rate | 12 months |
| Sofia |
| 1233 |
| Bulgaria |
| Site Reference ID/Investigator# 54279 | Sofia | 1408 | Bulgaria |
| Site Reference ID/Investigator# 54273 | Sofia | 1517 | Bulgaria |
| Site Reference ID/Investigator# 54267 | Brno | 62500 | Czechia |
| Site Reference ID/Investigator# 54282 | Ostrava-Vitkovice | 703 84 | Czechia |
| Site Reference ID/Investigator# 54283 | Prague | 169 02 | Czechia |
| Site Reference ID/Investigator# 54270 | Ústí nad Labem | 40113 | Czechia |
| Site Reference ID/Investigator# 54274 | Glostrup Municipality | 2600 | Denmark |
| Site Reference ID/Investigator# 54263 | Leipzig | 04103 | Germany |
| Site Reference ID/Investigator# 54284 | Münster | 48145 | Germany |
| Site Reference ID/Investigator# 54269 | Budapest | 1106 | Hungary |
| Site Reference ID/Investigator# 54277 | Győr | H-9023 | Hungary |
| Site Reference ID/Investigator# 54275 | Zalaegerszeg - Pozva | 8900 | Hungary |
| Site Reference ID/Investigator# 54272 | Udine | 33100 | Italy |
| Site Reference ID/Investigator# 54293 | Amsterdam | 1105 AZ | Netherlands |
| Site Reference ID/Investigator# 54265 | Gdansk | 80-147 | Poland |
| Site Reference ID/Investigator# 54266 | Katowice | 40-760 | Poland |
| Site Reference ID/Investigator# 54280 | Madrid | 28002 | Spain |
| Site Reference ID/Investigator# 54264 | Santiago de Compostela | 15705 | Spain |
| Site Reference ID/Investigator# 54271 | Liverpool | L7 8XP | United Kingdom |