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

EyePoint Pharmaceuticals, Inc.1 site in 1 country12 target enrollmentOctober 13, 2021

ConditionsUveitis Uveitis, Posterior Uveitis, Intermediate

InterventionsSham Injector FAI Insert

DrugsSham Injector FAI Insert

Overview

Phase: Phase 3
Intervention: Sham Injector
Conditions: Uveitis
Sponsor: EyePoint Pharmaceuticals, Inc.
Enrollment: 12
Locations: 1
Primary Endpoint: Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 13, 2021

End Date

April 12, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

EyePoint Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or non-pregnant female at least 18 years of age at time of consent.
•One or both eyes had a history of recurrent non-infectious uveitis affecting the posterior segment of the eye (intermediate, posterior, or panuveitis) with or without anterior uveitis \>1 year duration.
•During the 52 weeks prior to enrollment (Day 1), the subject must have received treatment for uveitis in the study eye with:
•Systemic corticosteroid or other systemic therapies for at least 12 consecutive or non-consecutive weeks, AND/OR
•at least 2 intra- or peri-ocular administrations of corticosteroid in the study eye, OR
•the study eye has experienced recurrence of uveitis at least 2 separate times requiring systemic, intra- or peri-ocular injection of corticosteroid.
•At the time of enrollment (Day 1), the study eye has \<10 anterior chamber cells/HPF (high power field) and a vitreous haze ≤ grade
•Visual acuity of study eye ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
•Not planning to undergo elective ocular surgery during the study.
•Able to understand and sign the Informed Consent Form (ICF).

Exclusion Criteria

•Ocular Exclusion Criteria (for the study eye, unless indicated otherwise):
•History of posterior uveitis only that is not accompanied by vitritis or macular edema.
•History of iritis only associated with no vitreous cells, anterior chamber cells, or vitreous haze at Day
•Uveitis with infectious etiology.
•Vitreous hemorrhage.
•Intraocular inflammation associated with a condition other than noninfectious uveitis (eg, intraocular lymphoma).
•Uveitis limited to the anterior segment, ie, anterior uveitis only.
•Ocular malignancy in either eye, including choroidal melanoma.
•Previous viral retinitis.
•Toxoplasmosis scar or scar related to previous viral retinitis in the study eye.

Arms & Interventions

Sham Comparator

Intravitreal sham injection

Intervention: Sham Injector

FAI insert (0.05 mg fluocinolone acetonide)

Fluocinolone acetonide (FA) intravitreal 0.05 mg insert (Yutiq 0.05 mg).

Intervention: FAI Insert

Outcomes

Primary Outcomes

Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24

Time Frame: Week 24

Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit; or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit.

Secondary Outcomes

Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52(Week 52)
Percentage of Subjects With Recurrence of Uveitis in the Fellow Eye at Weeks 24 and 52(Weeks 24 and 52)
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52(Weeks 24 and 52)
Number of Recurrences of Uveitis Within 24 and 52 Weeks(Weeks 24 and 52)
Time to Recurrence of Uveitis Through Weeks 24 and 52(Weeks 24 and 52)
Number of Adjunctive Treatments Required to Treat Recurrences of Uveitis at 24 and 52 Weeks(Weeks 24 and 52)
Percentage of Subjects With Recurrence of Iridocyclitis in the Study Eye Compared to Baseline at 24 and 52 Weeks(Weeks 24 and 52)
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12(At Day 28 and Months 2, 3, 6 and 12)