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

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

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.

Study Overview

• Status: Terminated
• Conditions: Uveitis; Uveitis, Posterior; Uveitis, Intermediate
• Intervention / Treatment: Drug: Sham Injector; Drug: FAI Insert

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • EyePoint Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)	Drug: FAI Insert; FAI insert; Other Names: Active Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who have a recurrence of uveitis in the study eye within 24 weeks (6 months) after receiving study treatment	24 weeks

Collaborators and Investigators

• Sponsor: EyePoint Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): October 17, 2022
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Uveitis; EyePoint; EYP-2102
• Additional Relevant MeSH Terms: Eye Diseases; Panuveitis; Uveal Diseases; Choroid Diseases; Choroiditis; Uveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis
• Other Study ID Numbers: EYP-2102-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No