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This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluocinolone acetonide | Experimental | Intravitreal fluocinolone acetonide implant |
|
| Standard care | Active Comparator | Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluocinolone acetonide intravitreal implant | Drug | surgical intravitreal implant of fluocinolone acetonide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of uveitis in the study eye. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline. | 33 months | |
| Number of recurrences | 33 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Pavesio, MD | Medical Retina Service/Moorfields Eye Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16690128 | Background | Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9. | |
| 20079922 |
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| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| D000305 | Adrenal Cortex Hormones |
| D007166 | Immunosuppressive Agents |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| corticosteroids and immunosuppressants | Drug | Systemic corticosteroids alone or combined with immunosuppressants |
|
| Number of recurrences compared to the 52 weeks prior to enrollment |
| 33 months |
| Change in quality of life indices | 33 months |
| Adjunctive treatment required | 33 months |
| Change in the size, if present at baseline, of the area of CME on fluorescein angiography | 33 months |
| Analysis of safety variables | 33 months |
| Percent of subjects who had at least one recurrence | 33 months |
| Pavesio C, Zierhut M, Bairi K, Comstock TL, Usner DW; Fluocinolone Acetonide Study Group. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 2010 Mar;117(3):567-75, 575.e1. doi: 10.1016/j.ophtha.2009.11.027. Epub 2010 Jan 15. |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |