Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis

NCT ID: NCT05322070

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2025-11-30

Brief Summary

A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.

Detailed Description

This is a prospective, phase 4, open-label, uncontrolled, 2-year follow-up study to evaluate the safety and efficacy of YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy. Patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye and will be followed for 24 months after treatment.

Conditions

Uveitis, Posterior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluocinolone Acetonide 0.18 mg

Fluocinolone Acetonide Intravitreal Implant 0.18 mg

Group Type: EXPERIMENTAL

Fluocinolone Acetonide Intravitreal Implant 0.18 mg

Intervention Type: DRUG

YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.

Interventions

Fluocinolone Acetonide Intravitreal Implant 0.18 mg

YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.

Intervention Type: DRUG

Other Intervention Names

YUTIQ 0.18 mg

Eligibility Criteria

Inclusion Criteria

• Male or female in good general health at least 18 years of age at time of consent.
• Presence of active, recurrent, unilateral or bilateral non-infectious uveitis affecting the posterior segment (intraocular inflammation) with a duration of at least 3 months from initial diagnosis, as determined by the Investigator. Intermediate or panuveitis will also be allowed if posterior segment involvement is part of the diagnosis.
• Posterior segment inflammation that has previously demonstrated a clinical response to ≥1 localized corticosteroid treatment (eg, topical steroid 2 to 4 times per day or intra- or peri-ocular injection).
• Presence of macular edema as measured by spectral-domain - optical coherence tomography (SD-OCT) (≥325 microns on Heidelberg SPECTRALIS and ≥315 microns on Zeiss CIRRUS).
• Best corrected visual acuity (BCVA) of the study eye 35-75 letters on the ETDRS chart (Snellen range 20/30 to 20/200).
• Not planning to undergo elective ocular surgery during the study.
• Able to understand, sign the Informed Consent Form (ICF).
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

• History of macular edema due to diabetes, retinal vein occlusion (RVO), age-related macular degeneration (AMD), or any non-inflammatory cause.
• Intraocular inflammation with infectious etiology.
• Diagnosis of uncontrolled glaucoma or ocular hypertension at Screening, unless study eye is being treated with ≤2 intraocular pressure (IOP)-lowering medications and/or has been previously treated with an incisional surgical procedure OR glaucoma laser procedure resulting in stable IOP in the normal range (10 to 21 mmHg).
• Intraocular pressure >21 mmHg or concurrent therapy at Screening with >2 IOP-lowering pharmacologic agents in the study eye.
• Ocular malignancy in either eye, including choroidal melanoma.
• Previous viral retinitis.
• Toxoplasmosis scar or scar related to previous viral retinitis in the study eye.
• Ocular and periocular infections such as 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.
• Hypersensitivity to any of the ingredients contained in YUTIQ®.
• Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage).
• Any current retinal detachment or retinoschisis in insertion in the study eye.
• Chronic hypotony, defined as <6 mmHg for at least 1 month's duration, and documented on at least two separate visits.
• Ocular surgery within 12 weeks prior to Day 1.
• YAG laser capsulotomy within 30 days prior to Day 1.
• Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1.
• Prior intravitreal treatment with OZURDEX® within 12 weeks prior to Day 1.
• Prior intravitreal treatment with Triesence® or TRIVARIS™ (triamcinolone) within 12 weeks prior to Day 1.
• Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.
• Radiation to the head or neck within 2 years prior to Screening.
• Steroid allergy, particularly to fluocinolone.
• Any systemic condition that requires chronic systemic anti-inflammatory, steroid, or immunosuppressive therapy (subjects on a stable dose of oral prednisone <7.5 mg per day for a non-ocular indication may be included).
• Positive test for human immunodeficiency virus (HIV), tuberculosis, or syphilis in the past 2 years or during Screening.
• Any severe acute or chronic medical (eg, cancer diagnosis) or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and make the subject inappropriate for study enrollment.
• Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
• Treatment with an investigational drug or device 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 final study visit.

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

Sponsors

CBCC Global Research

NETWORK

Sponsor Role: collaborator

Alimera Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Cutino

Role: STUDY_CHAIR

Alimera Sciences Inc

Locations

Retina Consultants of Orange County

Fullerton, California, United States

Macula and Retina Institute

Glendale, California, United States

California Eye Specialists Medical Group

Pasadena, California, United States

Retinal Consultants Medical Group

Sacramento, California, United States

Retina Associates of Colorado

Lakewood, Colorado, United States

Advanced Research

Coral Springs, Florida, United States

Retina Specialists of Tampa

Wesley Chapel, Florida, United States

Marietta Eye Clinic

Marietta, Georgia, United States

Retinal Vitreal Consultants Ltd.

Chicago, Illinois, United States

Illinois Retina Associates, S.C.

Oak Park, Illinois, United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Opthalmic Consultants of Boston

Boston, Massachusetts, United States

Massachusets Eye Research and Surgery Institution

Waltham, Massachusetts, United States

Foundation for Vision Research

Grand Rapids, Michigan, United States

Midwest Vision Research Foundation at Pepose Vision Institute

Chesterfield, Missouri, United States

Retina Consultants

Fargo, North Dakota, United States

Retina Vitreous Associates

Toledo, Ohio, United States

Erie Retina Research, LLC

Erie, Pennsylvania, United States

Tennessee Retina

Nashville, Tennessee, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Retina Consultants of Texas

Katy, Texas, United States

Valley Retina Institute, PA

McAllen, Texas, United States

Medical Center Opthalmology Associates

San Antonio, Texas, United States

Countries

United States

Other Identifiers

EYP-YUT-002

Identifier Type: -

Identifier Source: org_study_id