Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis

• ClinicalTrials.gov Identifier: NCT02746991
• Recruitment Status: Completed
• First Posted: April 21, 2016
• Results First Posted: July 7, 2020
• Last Update Posted: July 21, 2020
• Sponsor: EyePoint Pharmaceuticals, Inc.
• Information provided by (Responsible Party): EyePoint Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: April 19, 2016
• First Posted Date: April 21, 2016
• Results First Submitted Date: June 17, 2020
• Results First Posted Date: July 7, 2020
• Last Update Posted Date: July 21, 2020
• Actual Study Start Date: June 2, 2015
• Actual Primary Completion Date: October 4, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 10, 2020)

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)

• Original Primary Outcome Measures (submitted: April 20, 2016): Recurrence of uveitis in study eye [ Time Frame: Six Months ]

Current Secondary Outcome Measures (submitted: July 10, 2020)

Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months [ Time Frame: 36 Months ]

Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population)

• Original Secondary Outcome Measures (submitted: April 20, 2016): Recurrence of uveitis in study eye [ Time Frame: Three Years ]
• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: April 20, 2016)

• Recurrence of Uveitis in the Fellow Eye [ Time Frame: One Year ]
• Recurrence of Uveitis in the Fellow Eye [ Time Frame: Three Years ]

Descriptive Information

• Brief Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis
• Official Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Posterior Uveitis
• Intermediate Uveitis
• Panuveitis

Intervention

• Drug: Sham Injection
  Placebo
  Other Name: Placebo
• Drug: FAI Insert
  Fluocinolone Acetonide
  Other Name: Fluocinolone Acetonide

Study Arms

• Sham Comparator: Sham Injection
  Sham Injection
  Intervention: Drug: Sham Injection
• Experimental: FAI Insert
  FAI Insert (0.18 mg fluocinolone acetonide)
  Intervention: Drug: FAI Insert

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 22, 2016): 153
• Original Estimated Enrollment (submitted: April 20, 2016): 150
• Actual Study Completion Date: October 4, 2019
• Actual Primary Completion Date: October 4, 2019 (Final data collection date for primary outcome measure)

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 2.
• 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

OR the study eye has experienced recurrence:

• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid

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
• Media opacity precluding evaluation of retina and vitreous
• Peripheral retinal detachment in area of insertion
• Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)
• IOP > 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye
• Chronic hypotony (< 6 mmHg)
• Ocular surgery on the study eye within 3 months prior to study Day 1
• Capsulotomy in study eye within 30 days prior to study Day 1
• Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1
• Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1
• Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1
• Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1
• Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy
• Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1
• Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis
• Systemic infection within 30 days prior to study Day 1
• Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study
• Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study
• Treatment with an investigational drug or device within 30 days prior to study 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 this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit
• Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT02746991
• Other Study ID Numbers: PSV-FAI-005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: EyePoint Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: EyePoint Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Flavio Leonin Jr., MD; EyePoint Pharmaceuticals, Inc.

• PRS Account: EyePoint Pharmaceuticals, Inc.
• Verification Date: July 2020