Fluocinolone Acetonide Implant for Posterior Uveitis

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Alimera Sciences

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.

Eligibility Criteria

Adults at least 18 years old with chronic non-infectious uveitis affecting the back of the eye, who've seen improvement with steroid treatments. They should have macular edema and a certain level of vision clarity. Excluded are those with high eye pressure on multiple medications, recent eye surgeries or infections, known allergies to YUTIQ ingredients, certain systemic conditions requiring steroids or immunosuppressants, pregnant women, and other specific ocular conditions.

Inclusion Criteria

I am at least 18 years old and in good health.

I am willing and able to follow the study's schedule and procedures.

Presence of macular edema as measured by spectral-domain - optical coherence tomography (SD-OCT) (≥325 microns on Heidelberg SPECTRALIS and ≥315 microns on Zeiss CIRRUS)

+5 more

Exclusion Criteria

My glaucoma or high eye pressure is under control with up to 2 medications or surgery.

I have not had eye surgery in the last 12 weeks.

I have not had radiation to my head or neck in the last 2 years.

+23 more

Participant Groups

The trial is testing YUTIQ® (Fluocinolone Acetonide Intravitreal Implant) for its effectiveness in controlling inflammation in the back part of the eye due to uveitis that has previously responded to steroids. The implant's safety profile will also be assessed.

1Treatment groups

Experimental Treatment

Group I: Fluocinolone Acetonide 0.18 mgExperimental Treatment1 Intervention

Fluocinolone Acetonide Intravitreal Implant 0.18 mg