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

Uveitis, Posterior Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322070
• Other study ID #: EYP-YUT-002
• Status: Recruiting
• Phase: Phase 4
• Start date: June 6, 2022
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: Alimera Sciences
• Contact: Harakh Shah
• Phone: +1 661 979 5892
• Email: harakh.shah[@]cbcc.global
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Uveitis
• Uveitis, Posterior

Intervention

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

Locations

Country	Name	City	State
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Opthalmic Consultants of Boston	Boston	Massachusetts
United States	Midwest Vision Research Foundation at Pepose Vision Institute	Chesterfield	Missouri
United States	Retinal Vitreal Consultants Ltd.	Chicago	Illinois
United States	Advanced Research	Coral Springs	Florida
United States	Erie Retina Research, LLC	Erie	Pennsylvania
United States	Retina Consultants	Fargo	North Dakota
United States	Retina Consultants of Orange County	Fullerton	California
United States	Macula and Retina Institute	Glendale	California
United States	Foundation for Vision Research	Grand Rapids	Michigan
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Retina Consultants of Texas	Katy	Texas
United States	Retina Associates of Colorado	Lakewood	Colorado
United States	Marietta Eye Clinic	Marietta	Georgia
United States	Valley Retina Institute, PA	McAllen	Texas
United States	Tennessee Retina	Nashville	Tennessee
United States	Illinois Retina Associates, S.C.	Oak Park	Illinois
United States	California Eye Specialists Medical Group	Pasadena	California
United States	Retinal Consultants Medical Group	Sacramento	California
United States	Medical Center Opthalmology Associates	San Antonio	Texas
United States	Retina Vitreous Associates	Toledo	Ohio
United States	Massachusets Eye Research and Surgery Institution	Waltham	Massachusetts
United States	Retina Specialists of Tampa	Wesley Chapel	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Alimera Sciences	CBCC Global Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BCVA	• Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.	Month 6
Primary	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	Recurrence of non-infectious inflammation	• 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
Secondary	Presence of vascular leakage	• Presence of vascular leakage as measured by wide field fluorescein angiography.	Months 1, 3, 6, 12, 18, and 24.
Secondary	Resolution of macular edema	• 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
Secondary	Change in BCVA letter score	• 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
Secondary	Change from baseline in CST	• Mean change from baseline in CST measured by SD-OCT in the study eye.	Months 1, 3, 12, 18, and 24