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This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OZURDEX® | Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of Diabetic Macular Edema. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone intravitreal implant | Drug | Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Baseline to Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Maximum Gain in BCVA | 24 Months | |
| Change from Baseline in BCVA | Baseline, Week 6, Months 6, 12, 18 and 24 | |
| Percentage of Participants with a Gain (Improvement) in BCVA of at Least 10 Letters from Baseline |
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Inclusion Criteria:
-Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice.
Exclusion Criteria:
-Patient not residing in metropolitan France.
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Patients treated with OZURDEX® in clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Mesnard | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre MGM | Aix-en-Provence | 13090 | France | |||
| Ballanger |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36967448 | Derived | Kodjikian L, Delcourt C, Creuzot-Garcher C, Massin P, Conrath J, Velard ME, Lassalle T, Pinchinat S, Dupont-Benjamin L. Prospective, Observational, Multicenter, Real-World Study of the Efficacy, Safety, and Pattern of Use of the Dexamethasone Intravitreal Implant in Diabetic Macular Edema in France: Short-Term Outcomes of LOUVRE 3. Ophthalmol Ther. 2023 Jun;12(3):1671-1692. doi: 10.1007/s40123-023-00662-8. Epub 2023 Mar 26. |
| Label | URL |
|---|---|
| More Information | View source |
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| Baseline, Week 6, Month 6, 12, 18 and 24 |
| Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline | Baseline, Week 6, Month 6, 12, 18 and 24 |
| Change from Baseline in Retinal Thickness | Baseline, Month 24 |
| Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline | Baseline, Month 24 |
| Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness | Month 24 |
| Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex® | Day 1 |
| Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections | Day 1 |
| Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes) | Day 1 |
| Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment) | Day 1 |
| Percentage of Participants Categorized by Conditions when Placed on Treatment (Patient Characteristics, Glycosylated Hemoglobin (HbA1c) Level Control, Blood Pressure Control, Prior Treatments, Prior Treatment Failure) | Day 1 |
| Percentage of Participants Categorized by Conditions when Use of Ozurdex® (Number of Injections, Number of Follow-up Visits, Criteria for Retreatment and Discontinuation of Treatment) | 24 Months |
| Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity | 24 Months |
| Percentage of Participants by Intra-ocular Pressure (IOP) Categories (≥25 and ≥35 mmHg) | 24 Months |
| Number of Participants with Intra-ocular Pressure (IOP) Changes >10 mmHg from Baseline | 24 Months |
| Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery | 24 Months |
| Number of Participants with Incident Cataracts | 24 Months |
| Number of Participants with Cataract Surgeries Related to Treatment or Injection | 24 Months |
| Percentage of Participants with Serious Adverse Events | 24 Months |
| Percentage of Participants with Death | 24 Months |
| Aulnay-sous-Bois |
| 93600 |
| France |
| CH BLOIS | Blois | 41016 | France |
| CH Avicennes Bobigny | Bobigny | 93000 | France |
| Centre Rétine Gallien à Bordeaux | Bordeaux | 33000 | France |
| CHU Bordeaux | Bordeaux | 33000 | France |
| CHU Brest | Brest | 29200 | France |
| CHI Créteil | Créteil | 94000 | France |
| CH SCORFF - Lorient | Lorient | 56100 | France |
| Hopital De La Croix Rousse | Lyon | 69004 | France |
| Clinique Monticelli | Marseille | 13008 | France |
| Hopital de la Timone | Marseille | 13385 | France |
| CHR Annecy | Metz-Tessy | 74370 | France |
| CHU Pasteur 2 | Nice | 06001 | France |
| Chno 1520 | Paris | 75012 | France |
| Hopital Saint Joseph | Paris | 75014 | France |
| Fondation Rothschild | Paris | 75019 | France |
| Lariboisiere | Paris | 75475 | France |
| COCHIN | Paris | 75679 | France |
| Hopital Poissy | Poissy | 78300 | France |
| Hôpital de La Milétrie Poitiers | Poitiers | 86021 | France |
| Hopital Saint Germain en Laye | Saint-Germain-en-Laye | 78100 | France |
| Centre OPHTA.Kervision | Saint-Herblain | 44800 | France |
| Maison Rouge | Strasbourg | 67000 | France |
| Chu Toulouse | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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