Noninfectious Posterior Uveitis Clinical Trial
Official title:
A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
| Verified date | December 2011 |
| Source | Bausch & Lomb Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 278 |
| Est. completion date | September 2005 |
| Est. primary completion date | September 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years and older |
| Eligibility |
Inclusion Criteria: - Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent, non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study, and had 'quiet' eyes at surgery Exclusion Criteria: - Coexisting medical or ocular conditions that would interfere with the study results |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke Eye Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch & Lomb Incorporated |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence of uveitis before and after implantation. | 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation | No | |
| Secondary | 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 | No | |
| Secondary | Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes. | 34 weeks, 1 year, 2 years and 3 years post-implantation | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | Results of QOL surveys pre- versus post-implantation | 34 weeks, 1 year, 2 years and 3 years post-implantation | No | |
| Secondary | Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes) | 34 weeks, 1 year, 2 years and 3 years post-implantation | No | |
| Secondary | Time to recurrence, between treatment group comparison | 34 weeks, 1 year, 2 years and 3 years post-implantation | No | |
| Secondary | Post implantation uveitis rate, between treatment group comparison | 34 weeks, 1 year, 2 years and 3 years post-implantation | No |