Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00407082
• Collaborator: (none)
• Enrollment: 278
• Location: 1
• Arms: 3
• Duration (Months): 57
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Noninfectious Posterior Uveitis	Drug: fluocinolone acetonide intravitreal implant; Drug: Fluocinolone acetonide 2.1mg	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 278 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2000
• Actual Primary Completion Date: Sep 1, 2005
• Actual Study Completion Date: Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluocinolone acetonide 0.59mg Fluocinolone acetonide ocular implant 0.59mg	Drug: fluocinolone acetonide intravitreal implant; Fluocinolone acetonide ocular implant 0.59mg
Experimental: Fluocinolone acetonide 2.1mg Fluocinolone acetonide ocular implant 2.1mg	Drug: Fluocinolone acetonide 2.1mg; Fluocinolone acetonide ocular implant 2.1mg
No Intervention: No intervention Fellow eye

Outcome Measures

Primary Outcome Measures

1. Recurrence of uveitis before and after implantation. [34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation]

Secondary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. Results of QOL surveys pre- versus post-implantation [34 weeks, 1 year, 2 years and 3 years post-implantation]

6. Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes) [34 weeks, 1 year, 2 years and 3 years post-implantation]

7. Time to recurrence, between treatment group comparison [34 weeks, 1 year, 2 years and 3 years post-implantation]

8. Post implantation uveitis rate, between treatment group comparison [34 weeks, 1 year, 2 years and 3 years post-implantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Eye Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Thomas A Crescuillo, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00407082
• Other Study ID Numbers: 415-001
• First Posted: Dec 4, 2006
• Last Update Posted: Dec 8, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Uveitis; Uveitis, Posterior; Fluocinolone Acetonide

Study Results

No Results Posted as of Dec 8, 2011