Non-infectious Uveitis Clinical Trial
— Louvre 2Official title:
Multicentre Longitudinal Study of the Prescription of Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye
| Verified date | July 2019 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 246 |
| Est. completion date | December 19, 2018 |
| Est. primary completion date | November 28, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: -Patient with non-infectious uveitis affecting the posterior segment of the eye. Exclusion Criteria: -Patient not residing in metropolitan France. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Amiens | Amiens | |
| France | IOP Institut Ophtalmologique de Picardie | Amiens | |
| France | Centre Rétine Gallien | Bordeaux | |
| France | Hopital Pellegrin | Bordeaux | |
| France | CHI de Créteil | Creteil | |
| France | CHU Dijon | Dijon | |
| France | Centre Pôle Vision Val d'Ouest | Ecully | |
| France | Hopital Claude Huriez | Lille | |
| France | Hopital De La Croix Rousse | Lyon | |
| France | Clinique Monticelli | Marseille | |
| France | Hopital de la Timone | Marseille | |
| France | Hopital Gui De Chauliac | Montpellier | |
| France | Hopital Hotel Dieu Et Hme | Nantes | |
| France | SEL Ophtalliance | Nantes | |
| France | CHU Pasteur 2 | Nice | |
| France | Fondation Rothschild | Paris | |
| France | GH Cochin St Vincent De Paul (AP-HP) | Paris | |
| France | GH Pitie Salpêtrière (AP-HP) | Paris | |
| France | Hôpital Lariboisière (AP-HP) | Paris | |
| France | Hopital La Milétrie | Poitiers | |
| France | Chu Toulouse | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants with Best Corrected Visual Acuity (BCVA) =15 Letters | 2 Months | ||
| Secondary | Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline | Baseline, Months 6 and 18 | ||
| Secondary | Change from Baseline in BCVA | Baseline, Months 2, 6 and 18 | ||
| Secondary | Change from Baseline in Vitreous Haze Score Using a 5-Point Scale | Baseline and Months 2, 6 and 18 | ||
| Secondary | Change from Baseline in Macular Thickness | Baseline, Months 2, 6 and 18 | ||
| Secondary | Percentage of Participants Categorized by Comorbidities (Diseases Associated with Inflammation, Other Ophthalmic Diseases, General Comorbidities) | 18 Months | ||
| Secondary | 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 | ||
| Secondary | Number of Repeat Treatments with OZURDEX® and Other Drugs | 18 Months | ||
| Secondary | Time Between Repeat Treatments with OZURDEX® and Other Drugs | 18 Months | ||
| Secondary | Percentage of Participants with Adverse Events (AEs) | 18 Months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05928754 -
Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS
|
N/A | |
| Terminated |
NCT00646425 -
The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis
|
Phase 2 | |
| Terminated |
NCT00456482 -
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant
|
Phase 2/Phase 3 | |
| Recruiting |
NCT00720928 -
Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease
|
Phase 4 | |
| Completed |
NCT04018599 -
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
|
Phase 1 | |
| Active, not recruiting |
NCT03634475 -
A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis
|
Phase 1/Phase 2 | |
| Completed |
NCT04207983 -
A 48 Week Study to Evaluate the Efficacy and Safety of Two (2) EYS606 Treatment Regimens in Subjects With Active Chronic Non-infectious Uveitis (CNIU)
|
Phase 2 | |
| Completed |
NCT02748512 -
Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis
|
Phase 3 | |
| Recruiting |
NCT02706704 -
Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis
|
Phase 2 | |
| Terminated |
NCT01032915 -
Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
|
Phase 3 | |
| Not yet recruiting |
NCT04105452 -
Study to Evaluate PL8177 in Subjects With Non Infectious Uveitis (NIU)
|
Phase 2 | |
| Terminated |
NCT01090310 -
Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
|
Phase 3 | |
| Completed |
NCT01694186 -
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
|
Phase 3 | |
| Completed |
NCT03308045 -
Evaluation of EYS606 in Patients With Non-infectious Posterior, Intermediate or Panuveitis
|
Phase 1/Phase 2 | |
| Completed |
NCT00468871 -
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
|
Phase 2/Phase 3 |