Clinical trial NCT05322070: Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis
Official title: Phase 4 Study of YUTIQ® (Fluocinolone Acetonide Intravitreal Implant) 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis (Intraocular Inflammation Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Uveitis, Posterior
Keywords: Intraocular Inflammation
Fluocinolone Acetonide Intravitreal Implant
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
Collaborators: name: CBCC Global Research
First posted: 2022-04-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in BCVA
timeFrame: Month 6
measure: Change in CST
timeFrame: Month 6
Secondary outcomes:
measure: Recurrence of non-infectious inflammation
timeFrame: Months 1, 3, 6, 12, 18, and 24
measure: Presence of vascular leakage
timeFrame: Months 1, 3, 6, 12, 18, and 24.
measure: Resolution of macular edema
timeFrame: Months 1, 3, 6, 12, 18, and 24
measure: Change in BCVA letter score
timeFrame: Day 14 and at Months 1, 3, 12, 18, and 24
measure: Change from baseline in CST
timeFrame: Months 1, 3, 12, 18, and 24
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Glendale
country: United States
facility: Macula and Retina Institute
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Lakewood
country: United States
facility: Retina Associates of Colorado
state: Colorado
city: Coral Springs
country: United States
facility: Advanced Research
state: Florida
city: Wesley Chapel
country: United States
facility: Retina Specialists of Tampa
state: Florida
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Chicago
country: United States
facility: Retinal Vitreal Consultants Ltd.
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates, S.C.
state: Illinois
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Boston
country: United States
facility: Opthalmic Consultants of Boston
state: Massachusetts
city: Waltham
country: United States
facility: Massachusets Eye Research and Surgery Institution
state: Massachusetts
city: Grand Rapids
country: United States
facility: Foundation for Vision Research
state: Michigan
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation at Pepose Vision Institute
state: Missouri
city: Fargo
country: United States
facility: Retina Consultants
state: North Dakota
city: Toledo
country: United States
facility: Retina Vitreous Associates
state: Ohio
city: Erie
country: United States
facility: Erie Retina Research, LLC
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: San Antonio
country: United States
facility: Medical Center Opthalmology Associates
state: Texas
Study officials:
affiliation: Alimera Sciences Inc
name: Antonio Cutino
role: STUDY_CHAIR
References: