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

NCT05322070 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: EYP-YUT-002
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 23

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.

Conditions

Uveitis, Posterior

Keywords

Intraocular Inflammation; Fluocinolone Acetonide Intravitreal Implant

Outcome Measures

Primary Outcomes (2)

• Change in BCVA

  • Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.

  Month 6

• Change in CST

  • Mean change from baseline central subfield thickness (CST, also known as central foveal thickness) measured by SD-OCT in the study eye.

  Month 6

Secondary Outcomes (5)

• Recurrence of non-infectious inflammation

  Months 1, 3, 6, 12, 18, and 24

• Presence of vascular leakage

  Months 1, 3, 6, 12, 18, and 24.

• Resolution of macular edema

  Months 1, 3, 6, 12, 18, and 24

• Change in BCVA letter score

  Day 14 and at Months 1, 3, 12, 18, and 24

• Change from baseline in CST

  Months 1, 3, 12, 18, and 24

Study Arms (1)

Fluocinolone Acetonide 0.18 mg

EXPERIMENTAL

Fluocinolone Acetonide Intravitreal Implant 0.18 mg

Drug: Fluocinolone Acetonide Intravitreal Implant 0.18 mg

Interventions

Fluocinolone Acetonide Intravitreal Implant 0.18 mg DRUG

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

Also known as: YUTIQ 0.18 mg

Fluocinolone Acetonide 0.18 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alimera Sciences: lead
• CBCC Global Research: collaborator

Study Sites (23)

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Macula and Retina Institute

Glendale, California, 91203, United States

Location

California Eye Specialists Medical Group

Pasadena, California, 91107, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

Location

Retina Associates of Colorado

Lakewood, Colorado, 80228, United States

Location

Advanced Research

Coral Springs, Florida, 33067, United States

Location

Retina Specialists of Tampa

Wesley Chapel, Florida, 33544, United States

Location

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

Location

Retinal Vitreal Consultants Ltd.

Chicago, Illinois, 60616, United States

Location

Illinois Retina Associates, S.C.

Oak Park, Illinois, 60304, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Opthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Massachusets Eye Research and Surgery Institution

Waltham, Massachusetts, 02451, United States

Location

Foundation for Vision Research

Grand Rapids, Michigan, 49546, United States

Location

Midwest Vision Research Foundation at Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

Retina Consultants

Fargo, North Dakota, 58104, United States

Location

Retina Vitreous Associates

Toledo, Ohio, 43623, United States

Location

Erie Retina Research, LLC

Erie, Pennsylvania, 16507, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Texas

Katy, Texas, 77494, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Medical Center Opthalmology Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Uveitis, Posterior; Uveitis

Interventions

Fluocinolone Acetonide

Condition Hierarchy (Ancestors)

Panuveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Antonio Cutino

  Alimera Sciences Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 11, 2022
• Study Start: June 6, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)