Overview

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.