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

Sponsor
EyePoint Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05322070
Collaborator
CBCC Global Research (Other)
125
Enrollment
17
Locations
1
Arm
26.9
Anticipated Duration (Months)
7.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fluocinolone Acetonide Intravitreal Implant 0.18 mg
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 6, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fluocinolone Acetonide 0.18 mg

Fluocinolone Acetonide Intravitreal Implant 0.18 mg

Drug: Fluocinolone Acetonide Intravitreal Implant 0.18 mg
YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.
Other Names:
  • YUTIQ 0.18 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in BCVA [Month 6]

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

    2. Change in CST [Month 6]

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

    Secondary Outcome Measures

    1. Recurrence of non-infectious inflammation [Months 1, 3, 6, 12, 18, and 24]

      • Time to recurrence of non-infectious inflammation in the study eye defined as an increase in CST.

    2. Presence of vascular leakage [Months 1, 3, 6, 12, 18, and 24.]

      • Presence of vascular leakage as measured by wide field fluorescein angiography.

    3. Resolution of macular edema [Months 1, 3, 6, 12, 18, and 24]

      • Proportion of subjects with resolution of macular edema (central subfield thickness CST) as measured by SD OCT.

    4. Change in BCVA letter score [Day 14 and at Months 1, 3, 12, 18, and 24]

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

    5. Change from baseline in CST [Months 1, 3, 12, 18, and 24]

      • Mean change from baseline in CST measured by SD-OCT in the study eye.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Associated Retina Consultants Phoenix Arizona United States 85020
    2 Macula and Retina Institute Glendale California United States 91203
    3 California Eye Specialists Medical Group Pasadena California United States 91107
    4 California Eye Specialist Medical Group Redlands California United States 92373
    5 Retina Specialists of Tampa Wesley Chapel Florida United States 33544
    6 Marietta Eye Clinic Marietta Georgia United States 30060
    7 Retinal Vitreal Consultants Ltd. Chicago Illinois United States 60616
    8 Illinois Retina Associates, S.C. Montgomery Illinois United States 60304
    9 Associated Vitreoretinal Uveitis Consultants Indianapolis Indiana United States 46290
    10 Foundation for Vision Research Grand Rapids Michigan United States 49546
    11 Midwest Vision Research Foundation at Pepose Vision Institute Chesterfield Missouri United States 63017
    12 Erie Retina Research, LLC Erie Pennsylvania United States 16507
    13 Tennessee Retina Nashville Tennessee United States 37203
    14 Retina Consultants of Texas Bellaire Texas United States 77401
    15 Retina Consultants of Texas Katy Texas United States 77494
    16 Valley Retina Institute, PA McAllen Texas United States 78503
    17 Athena Eye Institute San Antonio Texas United States 78231

    Sponsors and Collaborators

    • EyePoint Pharmaceuticals, Inc.
    • CBCC Global Research

    Investigators

    • Study Chair: Dario A Paggiarino, EyePoint Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EyePoint Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT05322070
    Other Study ID Numbers:
    • EYP-YUT-002
    First Posted:
    Apr 11, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by EyePoint Pharmaceuticals, Inc.
    Intraocular Inflammation
    Fluocinolone Acetonide Intravitreal Implant
    Additional relevant MeSH terms:
    Uveitis
    Uveitis, Posterior
    Fluocinolone Acetonide

    Study Results

    No Results Posted as of Aug 22, 2022