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

March 5, 2021 updated by: EyePoint Pharmaceuticals, Inc.

A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase 3, multi-national, 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 three years following treatment.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munster, Germany
        • Augenarzte am St. Franziskus Hospital
      • Tubingen, Germany
        • Universitatsklinikum Tubingen
  • Hungary
      • Budapest, Hungary
        • Bajcsy-Zsilinszky Kórház és Rendelőintézet
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • L. V. Prasad Eye Institute - Hospital
    • Bhubaneshwar
      • Patia, Bhubaneshwar, India
        • L.V. Prasad Eye Institute
    • Gujarat
      • Ahmedabad, Gujarat, India
        • C.H Nagri Municipal Eye Hospital
    • Mumbai
      • Parel, Mumbai, India
        • Seth G.S. Medical College & KEM Hospital
    • Pune
      • Hadapsar, Pune, India
        • PBMA'S H.V. Desai Eye Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India
        • King George's Medical University
  • Israel
      • Jerusalem, Israel
        • Hadassah University Hospital Ein Kerem
      • Petah Tikva, Israel
        • Rabin Medical Center
      • Qiryat Ono, Israel
        • Sheba Medical Center
  • United Kingdom
      • Belfast, United Kingdom
        • Royal Hospitals Trust
      • Birmingham, United Kingdom
        • Birmingham and Midland Eye Centre
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Gloucester, United Kingdom
        • Gloucestershire Royal Hospital
      • London, United Kingdom
        • Moorfields Eye Hospital
      • London, United Kingdom
        • St Thomas Hospital
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreaous Associates
      • Sacramento, California, United States, 95819
        • Retinal Consultants Medical Group, Inc
      • Torrance, California, United States, 90503
        • Retina Macula Institute
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Ophthalmology & Visual Sciences
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02142
        • Ocular Immunology and Uveitis Foundation
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • Slingerlands, New York, United States, 12159
        • Retina Consultants
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Casey Eye Institute
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston
      • San Antonio, Texas, United States, 78240
        • Foresight Studies, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • 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 injections 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
  • At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/HPF and a vitreous haze ≤ grade 2.
  • Visual acuity of study eye is at least 15 letters on the 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

Exclusion Criteria

  • Allergy to fluocinolone acetonide or any component of the 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 structure
  • 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 IOP in the normal range (10-21 mmHg)
  • Intraocular pressure (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 test positive for human immune deficiency virus (HIV) or syphilis during screening
  • Mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: sham injection
Drug: Sham injection
Other Names:
  • Sham Comparator
EXPERIMENTAL: FAI insert
FAI insert (0.18 mg fluocinolone acetonide)
Drug: FAI insert
Other Names:
  • Active Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit
Time Frame: 36 months
Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyePoint Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Glenn Jaffe, MD, Duke University Eye Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 2, 2013

Primary Completion (ACTUAL)

March 26, 2018

Study Completion (ACTUAL)

March 26, 2018

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (ESTIMATE)

September 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSV-FAI-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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