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Business decision to stop the program.
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This observational study will evaluate the safety, efficacy, characteristics of patients, characteristics of physicians and quality of life in patients who are prescribed OZURDEX® as treatment for non-infectious uveitis of the posterior segment of the eye in France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OZURDEX® | Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of non-infectious uveitis affecting the posterior segment of the eye. |
|
| 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 |
|---|---|---|
| Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters | 2 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline | Baseline, Months 6 and 18 | |
| Change from Baseline in BCVA | Baseline, Months 2, 6 and 18 | |
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Inclusion Criteria:
-Patient with non-infectious uveitis affecting the posterior segment of the eye.
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 |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80000 | France | |||
| IOP Institut Ophtalmologique de Picardie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35802252 | Derived | Bodaghi B, Brezin AP, Weber M, Delcourt C, Kodjikian L, Provost A, Velard ME, Barnier-Ripet D, Pinchinat S, Dupont-Benjamin L. Real-Life Efficacy, Safety, and Use of Dexamethasone Intravitreal Implant in Posterior Segment Inflammation Due to Non-infectious Uveitis (LOUVRE 2 Study). Ophthalmol Ther. 2022 Oct;11(5):1775-1792. doi: 10.1007/s40123-022-00525-8. Epub 2022 Jul 8. |
| Label | URL |
|---|---|
| More Information | View source |
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| Change from Baseline in Vitreous Haze Score Using a 5-Point Scale |
| Baseline and Months 2, 6 and 18 |
| Change from Baseline in Macular Thickness | Baseline, Months 2, 6 and 18 |
| Percentage of Participants Categorized by Comorbidities (Diseases Associated with Inflammation, Other Ophthalmic Diseases, General Comorbidities) | 18 Months |
| Change from Baseline in the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ25) Score Using a 25 Item Questionnaire | Baseline, Months 2 and 18 |
| Number of Repeat Treatments with OZURDEX® and Other Drugs | 18 Months |
| Time Between Repeat Treatments with OZURDEX® and Other Drugs | 18 Months |
| Percentage of Participants with Adverse Events (AEs) | 18 Months |
| Amiens |
| 80000 |
| France |
| Centre Rétine Gallien | Bordeaux | 33000 | France |
| Hopital Pellegrin | Bordeaux | 33076 | France |
| CHI de Créteil | Créteil | 94000 | France |
| CHU Dijon | Dijon | 21079 | France |
| Centre Pôle Vision Val d'Ouest | Écully | 69130 | France |
| Hopital Claude Huriez | Lille | 59037 | France |
| Hopital De La Croix Rousse | Lyon | 69317 | France |
| Clinique Monticelli | Marseille | 13 008 | France |
| Hopital de la Timone | Marseille | 13385 | France |
| Hopital Gui De Chauliac | Montpellier | 34000 | France |
| SEL Ophtalliance | Nantes | 44000 | France |
| Hopital Hotel Dieu Et Hme | Nantes | 44093 | France |
| CHU Pasteur 2 | Nice | 06000 | France |
| Hôpital Lariboisière (AP-HP) | Paris | 75010 | France |
| GH Pitie Salpêtrière (AP-HP) | Paris | 75013 | France |
| GH Cochin St Vincent De Paul (AP-HP) | Paris | 75014 | France |
| Fondation Rothschild | Paris | 75019 | France |
| Hopital La Milétrie | Poitiers | 86021 | France |
| Chu Toulouse | Toulouse | 31000 | 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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