ActivePhase 2Phase 3ACTRN12605000485639

A Multicenter, Randomized, Double-Masked Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) Implant in Patients with Non-Infectious Uveitis Affecting the Posterior Segment of the Eye


Sponsor

Bausch & Lomb (Rochester)

Enrollment

40 participants

Start Date

Apr 1, 2002

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 6 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests an eye implant that slowly releases the steroid fluocinolone to treat non-infectious uveitis affecting the back of the eye. Both men and women aged 6 and older with a history of posterior uveitis lasting more than one year are eligible. Participation involves receiving the eye implant and attending regular eye examinations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a 3 year multicenter, randomized, double-masked controlled study to evaluate the safety and efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) implant in patients with unilat

This is a 3 year multicenter, randomized, double-masked controlled study to evaluate the safety and efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) implant in patients with unilateral or bilateral non-infectious uveitis affecting the posterior segment of the eye. Eligible subjects will receive either a 0.59mg or 2.1mg implant (assigned according to a randomization code) surgically inserted in one eye. In patients with bilateral disease, the more severely affected eye will be implanted. Subjects will be followed for a period of 3 years, the approximate time period over which the implants are designed to release FA.


Locations(1)

Australia

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ACTRN12605000485639