Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Waltham, Massachusetts
Dates
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Uveitis, Uveitis, Posterior, Uveitis, Intermediate, EYP-2102, EyePoint, Pars Planitis, FAI Insert, FAI insert (0.05 mg fluocinolone acetonide)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • EyePoint Study Site accepting new patients
    Waltham Massachusetts 02451 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
EyePoint Pharmaceuticals, Inc.
Links
Sign up for this study
ID
NCT05070728
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated