TerminatedPhase 2/3

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

Stopped: SARS epidemic in Asia and Canada

239 participantsStarted 2002-05

Plain-language summary

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.

Who can participate

Age range6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, * Had clinically 'quiet' eyes at surgery. Exclusion Criteria: * Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.

What they're measuring

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.

Timeframe: 1 year pre-implantation; 3 years post-implantation

Trial details

NCT IDNCT00456482

SponsorBausch & Lomb Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-04

View on ClinicalTrials.gov More Non-infectious Uveitis trials