NCT05322070

Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis

Phase 4 Study of YUTIQ® (Fluocinolone Acetonide Intravitreal Implant) 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis (Intraocular Inflammation Study)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Alimera Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, phase 4, open-label, uncontrolled, 2-year follow-up study to evaluate the safety and efficacy of YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy. Patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye and will be followed for 24 months after treatment.

Conditions

• Uveitis, Posterior

Interventions

Type	Name	Description
DRUG	Fluocinolone Acetonide Intravitreal Implant 0.18 mg	YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.

Timeline

• Start date: 2022-06-06
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2022-04-11
• Last updated: 2024-08-06

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study