Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert

NCT ID: NCT01694186

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-02
• Study Completion Date: 2018-03-26

Brief 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.

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.

Conditions

Non-Infectious Uveitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sham injection

sham injection

Group Type: SHAM_COMPARATOR

Sham injection

Intervention Type: DRUG

FAI insert

FAI insert (0.18 mg fluocinolone acetonide)

Group Type: EXPERIMENTAL

FAI insert

Intervention Type: DRUG

Interventions

FAI insert

Intervention Type: DRUG

Sham injection

Intervention Type: DRUG

Other Intervention Names

Active Drug; Sham Comparator

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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EyePoint Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Jaffe, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Eye Center

Locations

Retina Vitreaous Associates

Beverly Hills, California, United States

Retinal Consultants Medical Group, Inc

Sacramento, California, United States

Retina Macula Institute

Torrance, California, United States

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, United States

Northwestern University

Chicago, Illinois, United States

Ophthalmology & Visual Sciences

Lexington, Kentucky, United States

Ocular Immunology and Uveitis Foundation

Cambridge, Massachusetts, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Retina Consultants

Slingerlands, New York, United States

Duke University Eye Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

OHSU Casey Eye Institute

Portland, Oregon, United States

Charleston Neuroscience Institute

Ladson, South Carolina, United States

Texas Retina Associates

Arlington, Texas, United States

Retina Consultants of Houston

Houston, Texas, United States

Foresight Studies, LLC

San Antonio, Texas, United States

Augenarzte am St. Franziskus Hospital

Münster, , Germany

Universitatsklinikum Tubingen

Tübingen, , Germany

Bajcsy-Zsilinszky Kórház és Rendelőintézet

Budapest, , Hungary

L. V. Prasad Eye Institute - Hospital

Hyderabad, Andhra Pradesh, India

L.V. Prasad Eye Institute

Patia, Bhubaneshwar, India

C.H Nagri Municipal Eye Hospital

Ahmedabad, Gujarat, India

Seth G.S. Medical College & KEM Hospital

Pārel, Mumbai, India

PBMA'S H.V. Desai Eye Hospital

Hadapsar, Pune, India

King George's Medical University

Lucknow, Uttar Pradesh, India

Hadassah University Hospital Ein Kerem

Jerusalem, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Sheba Medical Center

Qiryat Ono, , Israel

Royal Hospitals Trust

Belfast, , United Kingdom

Birmingham and Midland Eye Centre

Birmingham, , United Kingdom

Bradford Royal Infirmary

Bradford, , United Kingdom

Gloucestershire Royal Hospital

Gloucester, , United Kingdom

Moorfields Eye Hospital

London, , United Kingdom

St Thomas Hospital

London, , United Kingdom

Countries

United States; Germany; Hungary; India; Israel; United Kingdom

References

Jaffe GJ, Pavesio CE; Study Investigators. Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis: Three-Year Results. Ophthalmology. 2020 Oct;127(10):1395-1404. doi: 10.1016/j.ophtha.2020.04.001. Epub 2020 Apr 17.

Reference Type: DERIVED

PMID: 32624244 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PSV-FAI-001

Identifier Type: -

Identifier Source: org_study_id