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This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluocinolone acetonide 0.59mg | Experimental | Fluocinolone acetonide ocular implant 0.59mg |
|
| Fluocinolone acetonide 2.1mg | Experimental | Fluocinolone acetonide ocular implant 2.1mg |
|
| No intervention | No Intervention | Fellow eye |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluocinolone acetonide intravitreal implant | Drug | Fluocinolone acetonide ocular implant 0.59mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of uveitis before and after implantation. | 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes. | 34 weeks, 1 year, 2 years and 3 years post-implantation | |
| Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Crescuillo | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16690128 | Result | 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. | |
| 18779477 |
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| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Fluocinolone acetonide 2.1mg | Drug | Fluocinolone acetonide ocular implant 2.1mg |
|
| 34 weeks, 1 year, 2 years and 3 years post-implantation |
| The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation) | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes) | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Results of QOL surveys pre- versus post-implantation | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes) | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Time to recurrence, between treatment group comparison | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Post implantation uveitis rate, between treatment group comparison | 34 weeks, 1 year, 2 years and 3 years post-implantation |
| Callanan DG, Jaffe GJ, Martin DF, Pearson PA, Comstock TL. Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008 Sep;126(9):1191-201. doi: 10.1001/archopht.126.9.1191. |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |