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

Uveitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05070728
• Other study ID #: EYP-2102-001
• Status: Terminated
• Phase: Phase 3
• Start date: November 17, 2021
• Est. completion date: April 12, 2023

Study information

• Verified date: September 2023
• Source: EyePoint Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 12, 2023
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Uveitis
• Uveitis, Intermediate
• Uveitis, Posterior

Intervention

Drug:
• Sham Injector
Sham injection
• FAI Insert
FAI insert

Locations

Country	Name	City	State
United States	EyePoint Study Site	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EyePoint Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who have a recurrence of uveitis in the study eye within 24 weeks (6 months) after receiving study treatment		24 weeks