NCT05322070
Active, not recruiting
Phase 4
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)
ConditionsUveitis, Posterior
InterventionsFluocinolone Acetonide Intravitreal Implant 0.18 mg
Overview
- Phase
- Phase 4
- Intervention
- Fluocinolone Acetonide Intravitreal Implant 0.18 mg
- Conditions
- Uveitis, Posterior
- Sponsor
- Alimera Sciences
- Enrollment
- 125
- Locations
- 22
- Primary Endpoint
- Change in BCVA
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
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).
Arms & Interventions
Fluocinolone Acetonide 0.18 mg
Fluocinolone Acetonide Intravitreal Implant 0.18 mg
Intervention: Fluocinolone Acetonide Intravitreal Implant 0.18 mg
Outcomes
Primary Outcomes
Change in BCVA
Time Frame: Month 6
• Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.
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.
Secondary Outcomes
- 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)
- Recurrence of non-infectious inflammation(Months 1, 3, 6, 12, 18, and 24)
Study Sites (22)
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