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

Running, not enrolling · Phase 4

Conditions studied: Uveitis, Posterior

In brief

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.

Key facts

Study ID

NCT05322070

Run by

Alimera Sciences

People needed

125

Starts

2022-06-06

Expected to finish

2025-11-01

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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