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Fluocinolone Acetonide Implant in Non-Infectious Posterior Uveitis
NCT00456482Phase 3
Key facts
- Status
- Terminated
- Start
- May 2002
- Primary completion
- Apr 2006
- Sponsor
- Bausch + Lomb
- Modality
- Orthosteric Ligands
- Conditions
- noninfectious uveitis (NIU)
01
Overview
Phase 3, randomised, double-blind trial of fluocinolone acetonide in noninfectious uveitis (NIU) (3 arms), sponsored by Bausch + Lomb. Primary endpoint: Recurrence of uveitis before and after implantation. Started May 2002; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Fluocinolone Acetonide 0.59mg
Fluocinolone acetonide intravitreal implant 0.59mg
Fluocinolone Acetonide 2.1mg
Fluocinolone acetonide intravitreal implant 2.1mg
No Intervention
Fellow eye (Control)
03
Who it enrols
Patients at least 6 years old with recurrent non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year, who have been treated for the condition and have clinically 'quiet' eyes at surgery.
04
Endpoints
Primary
Recurrence of uveitis before and after implantation
Secondary
Time to first recurrence of uveitis
Need for adjunctive uveitis treatment
Reduction in the area of cystoid macular edema
Quality of Life
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