- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05322070
Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis
October 26, 2023 updated by: Alimera Sciences
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)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
125
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Harakh Shah
- Phone Number: +1 661 979 5892
- Email: harakh.shah@cbcc.global
Study Contact Backup
- Name: Niti Rao
- Phone Number: +91 837 398 4498
- Email: niti.rao@cbcc.global
Study Locations
-
-
California
-
Fullerton, California, United States, 92835
- Recruiting
- Retina Consultants of Orange County
-
Glendale, California, United States, 91203
- Recruiting
- Macula and Retina Institute
-
Pasadena, California, United States, 91107
- Recruiting
- California Eye Specialists Medical Group
-
Sacramento, California, United States, 95825
- Recruiting
- Retinal Consultants Medical Group
-
-
Colorado
-
Lakewood, Colorado, United States, 80228
- Recruiting
- Retina Associates of Colorado
-
-
Florida
-
Coral Springs, Florida, United States, 33067
- Recruiting
- Advanced Research
-
Wesley Chapel, Florida, United States, 33544
- Recruiting
- Retina Specialists of Tampa
-
-
Georgia
-
Marietta, Georgia, United States, 30060
- Recruiting
- Marietta Eye Clinic
-
-
Illinois
-
Chicago, Illinois, United States, 60616
- Recruiting
- Retinal Vitreal Consultants Ltd.
-
Oak Park, Illinois, United States, 60304
- Recruiting
- Illinois Retina Associates, S.C.
-
-
Maryland
-
Hagerstown, Maryland, United States, 21740
- Recruiting
- Cumberland Valley Retina Consultants
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Opthalmic Consultants of Boston
-
Waltham, Massachusetts, United States, 02451
- Recruiting
- Massachusets Eye Research and Surgery Institution
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49546
- Recruiting
- Foundation for Vision Research
-
-
Missouri
-
Chesterfield, Missouri, United States, 63017
- Recruiting
- Midwest Vision Research Foundation at Pepose Vision Institute
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- Recruiting
- Retina Consultants
-
-
Ohio
-
Toledo, Ohio, United States, 43623
- Recruiting
- Retina Vitreous Associates
-
-
Pennsylvania
-
Erie, Pennsylvania, United States, 16507
- Recruiting
- Erie Retina Research, LLC
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Tennessee Retina
-
-
Texas
-
Bellaire, Texas, United States, 77401
- Recruiting
- Retina Consultants of Texas
-
Katy, Texas, United States, 77494
- Recruiting
- Retina Consultants of Texas
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McAllen, Texas, United States, 78503
- Recruiting
- Valley Retina Institute, PA
-
San Antonio, Texas, United States, 78240
- Recruiting
- Medical Center Opthalmology Associates
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fluocinolone Acetonide 0.18 mg
Fluocinolone Acetonide Intravitreal Implant 0.18 mg
|
YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in BCVA
Time Frame: Month 6
|
• Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.
|
Month 6
|
Change in CST
Time Frame: Month 6
|
• 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of non-infectious inflammation
Time Frame: 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.
|
Months 1, 3, 6, 12, 18, and 24
|
Presence of vascular leakage
Time Frame: Months 1, 3, 6, 12, 18, and 24.
|
• Presence of vascular leakage as measured by wide field fluorescein angiography.
|
Months 1, 3, 6, 12, 18, and 24.
|
Resolution of macular edema
Time Frame: 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.
|
Months 1, 3, 6, 12, 18, and 24
|
Change in BCVA letter score
Time Frame: 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.
|
Day 14 and at Months 1, 3, 12, 18, and 24
|
Change from baseline in CST
Time Frame: Months 1, 3, 12, 18, and 24
|
• Mean change from baseline in CST measured by SD-OCT in the study eye.
|
Months 1, 3, 12, 18, and 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Antonio Cutino, Alimera Sciences Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2022
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
March 2, 2022
First Submitted That Met QC Criteria
April 4, 2022
First Posted (Actual)
April 11, 2022
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EYP-YUT-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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