Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

Bausch + Lomb

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Non-infectious Uveitis

Treatments: Drug: Fluocinolone Acetonide 0.59mg; Drug: Fluocinolone Acetonide 2.1mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00456482

415-004

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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239 participants in 3 patient groups

Fluocinolone Acetonide 0.59mg

Experimental group

Description:

Fluocinolone acetonide intravitreal implant 0.59mg

Treatment:

Drug: Fluocinolone Acetonide 0.59mg

Fluocinolone Acetonide 2.1mg

Experimental group

Description:

Fluocinolone acetonide intravitreal implant 2.1mg

Treatment:

Drug: Fluocinolone Acetonide 2.1mg

No Intervention

No Intervention group

Description:

Fellow eye