NCT05070728

Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal (FAI) Insert

A Phase 3, Multicenter, Prospective, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide (FA) Intravitreal 0.05 mg Insert (Yutiq 0.05 mg) in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: EyePoint Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the safety and efficacy of a fluocinolone acetonide intravitreal (FAI) insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.

Detailed description

This was a phase 3, multicenter, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable FAI insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Subjects were randomized to receive either a sham injection or the FAI insert and were observed for 1 year following treatment.

Conditions

• Uveitis
• Uveitis, Posterior
• Uveitis, Intermediate

Interventions

Type	Name	Description
DRUG	Sham Injector	Intravitreal sham injection
DRUG	FAI Insert	Yutiq 0.05 mg contains 0.05 mg FA and was designed to deliver FA into the vitreous humor for at least 24 weeks. Yutiq 0.05 mg was administered to the study eye by injection through the pars plana using a pre-loaded applicator with a 25-gauge needle.

Timeline

• Start date: 2021-10-13
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2021-10-07
• Last updated: 2024-12-19
• Results posted: 2024-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study