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

Sponsor

EyePoint Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05070728

Collaborator

(none)

Enrollment

Location

Arms

16.4

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.

Condition or Disease	Intervention/Treatment	Phase
Uveitis Uveitis, Posterior Uveitis, Intermediate	Drug: Sham Injector Drug: FAI Insert	Phase 3

Detailed Description

This is a phase 3, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for one year following treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 17, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham Comparator sham injection	Drug: Sham Injector Sham injection Other Names: Sham Comparator
Active Comparator: FAI insert (0.05 mg fluocinolone acetonide) FAI insert (0.05 mg fluocinolone acetonide)	Drug: FAI Insert FAI insert Other Names: Active Drug

Arm

Intervention/Treatment

Sham Comparator: Sham Comparator

sham injection

Drug: Sham Injector

Sham injection

Other Names:

Sham Comparator

Active Comparator: FAI insert (0.05 mg fluocinolone acetonide)

FAI insert (0.05 mg fluocinolone acetonide)

Drug: FAI Insert

FAI insert

Other Names:

Active Drug

Outcome Measures

Primary Outcome Measures

Proportion of subjects who have a recurrence of uveitis in the study eye within 24 weeks (6 months) after receiving study treatment [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or non-pregnant female at least 18 years of age at time of consent
One or both eyes having 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 study eye has either received treatment systemic corticosteroid or other systemic therapies given for at least 12 weeks, and/or at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis OR the study eye has experienced recurrence recurrences of uveitis at least 2 separate times requiring systemic, intra- or peri-ocular injection of corticosteroid.
Subject is not planning to undergo elective ocular surgery during the study
Subject has ability to understand and sign the Informed Consent Form (ICF).
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

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 1.
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.
Requirement for chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy.
History of certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to Day 1.
Positive test for human immunodeficiency virus (HIV) or syphilis during Screening.
Mycobacterial uveitis or chorioretinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis.
Systemic infection within 30 days prior to Day 1.
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to Day 1 until the 52-week Visit.
Other protocol-specified exclusion criteria may apply.