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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

NCT00468871 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2011-12-08

No results posted yet for this study

Summary

This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.

Conditions

  • Non-infectious Uveitis

Interventions

DRUG

fluocinolone acetonide intravitreal implant

surgical intravitreal implant of fluocinolone acetonide

DRUG

corticosteroids and immunosuppressants

Systemic corticosteroids alone or combined with immunosuppressants

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Carlos Pavesio, MD · Medical Retina Service/Moorfields Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2006-06-30
Completion
2006-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00468871 on ClinicalTrials.gov