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

EYP-2102-001

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.

2021-11-17

2022-10-17

2023-04-12

Terminated

Early phase I

12

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

2023-09-08