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)

NCT05322070 Phase 4 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Alimera Sciences
Phase	Phase 4
Status	ACTIVE_NOT_RECRUITING
Enrolment	125
Start date	2022-06-06
Completion	2025-11

Conditions

• Uveitis, Posterior

Interventions

• Fluocinolone Acetonide Intravitreal Implant 0.18 mg

Primary outcomes

• Change in BCVA — Month 6
  • Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.
• Change in CST — Month 6
  • Mean change from baseline central subfield thickness (CST, also known as central foveal thickness) measured by SD-OCT in the study eye.

Countries

United States