A Multi-center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Overview
- Phase
- Phase 3
- Intervention
- FAI Insert
- Conditions
- Intermediate Uveitis
- Sponsor
- EyePoint Pharmaceuticals, Inc.
- Enrollment
- 153
- Locations
- 15
- Primary Endpoint
- Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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 chronic 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 three years following treatment.
Detailed Description
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 chronic 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 three years following treatment.
Investigators
Eligibility 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 with or without anterior uveitis \> 1 year duration
- •At the time of enrollment (Day 1), study eye has \< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade
- •Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
- •Subject is not planning to undergo elective ocular surgery during the study
- •Subject has ability to understand and sign the Informed Consent Form
- •Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- •During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:
- •systemic corticosteroid or other systemic therapies given for at least 3 months, and/or
- •at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis
Exclusion Criteria
- •Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert
- •History of posterior uveitis only that is not accompanied by vitritis or macular edema
- •History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
- •Uveitis with infectious etiology
- •Vitreous hemorrhage
- •Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)
- •Ocular malignancy in either eye, including choroidal melanoma
- •Toxoplasmosis scar in study eye or scar related to previous viral retinitis
- •Previous viral retinitis
- •Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures
Arms & Interventions
FAI Insert
FAI Insert (0.18 mg fluocinolone acetonide)
Intervention: FAI Insert
Sham Injection
Sham Injection
Intervention: Sham Injection
Outcomes
Primary Outcomes
Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months
Time Frame: 6 Months
Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)
Secondary Outcomes
- Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months(36 Months)