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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

NCT00407082 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2011-12-08

No results posted yet for this study

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.

Conditions

  • Noninfectious Posterior Uveitis

Interventions

DRUG

fluocinolone acetonide intravitreal implant

Fluocinolone acetonide ocular implant 0.59mg

DRUG

Fluocinolone acetonide 2.1mg

Fluocinolone acetonide ocular implant 2.1mg

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Thomas A Crescuillo · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-12-31
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • United States

Study Locations

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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 NCT00407082 on ClinicalTrials.gov