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

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

Criteria

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.