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
Verified date | September 2023 |
Source | EyePoint Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | EyePoint Study Site | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
EyePoint Pharmaceuticals, Inc. |
United States,
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 |
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