Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
SARS epidemic in Asia and Canada
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluocinolone Acetonide 0.59mg | Experimental | Fluocinolone acetonide intravitreal implant 0.59mg |
|
| Fluocinolone Acetonide 2.1mg | Experimental | Fluocinolone acetonide intravitreal implant 2.1mg |
|
| No Intervention | No Intervention | Fellow eye |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluocinolone Acetonide 0.59mg | Drug | Fluocinolone Acetonide Intravitreal Implant 0.59 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye. | 1 year pre-implantation; 3 years post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys. | 1 year pre-implantation; 3 years post-implantation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy L Comstock, OD | Bausch & Lomb Incorporated | Study Director |
Not provided
| 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluocinolone Acetonide 2.1mg | Drug | Fluocinolone Acetonide Intravitreal Implant 2.1 mg |
|
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |