DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Noninfectious Posterior Uveitis

Intervention: fluocinolone acetonide intravitreal implant (Drug); Fluocinolone acetonide 2.1mg (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Thomas A Crescuillo, Study Director, Affiliation: Bausch & Lomb Incorporated

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Recurrence of uveitis before and after implantation.

Secondary outcome:

Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.

Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes.

The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation)

Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes)

Results of QOL surveys pre- versus post-implantation

Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes)

Time to recurrence, between treatment group comparison

Post implantation uveitis rate, between treatment group comparison

Eligibility

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Duke Eye Center, Durham, North Carolina 27710, United States
Additional Information

Starting date: December 2000
Last updated: December 7, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017