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Compares treatment options for Uveitis
Official title The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
ClinicalTrials.gov ID: NCT05486468
What this study is testing
What is Yutiq 0.18 MG Drug Implant?
Yutiq 0.18 MG Drug Implant is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for uveitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General
- Male or non-pregnant female in good general health at least 18 years of age, understands the language of the informed consent, and is willing and...
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Ocular (Study Eye):
- Diagnosed with chronic unilateral or bilateral noninfectious posterior segment inflammation (with or without anterior uveitis) that demonstrated a...
- Presence of active posterior segment inflammation as determined by the Investigator.
You likely can't join if
- General Exclusion Criteria:
- people with known hypersensitivity to any components of YUTIQ.
- Female people who are pregnant or breastfeeding.
- Has any acute or chronic medical disease or psychiatric condition that, in the opinion of the Investigator, would preclude participation in the study...
- History of anterior uveitis only (without associated uveitis that affected the posterior segment).
- Presence of a vitreous hemorrhage.
See the full eligibility criteria
- General
- Male or non-pregnant female in good general health at least 18 years of age, understands the language of the informed consent, and is willing and able to provide written informed consent and sign/date a health...
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Ocular (Study Eye):
- Diagnosed with chronic unilateral or bilateral noninfectious posterior segment inflammation (with or without anterior uveitis) that demonstrated a clinical response to ≥1 previous corticosteroid treatment of any...
- Presence of active posterior segment inflammation as determined by the Investigator.
- Vitreous haze grade ≥ 2 based on the standardization of uveitis nomenclature (SUN) criteria.
- Less than 10 anterior chamber cells/high power field determined by slit lamp examination.
- Not planning to undergo elective ocular surgery during the study.
- General Exclusion Criteria:
- people with known hypersensitivity to any components of YUTIQ.
- Female people who are pregnant or breastfeeding.
- Has any acute or chronic medical disease or psychiatric condition that, in the opinion of the Investigator, would preclude participation in the study or put the subject at risk due to study treatment or procedures...
- History of anterior uveitis only (without associated uveitis that affected the posterior segment).
- Presence of a vitreous hemorrhage.
- Uveitis with infectious etiology.
- Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma).
- Current infectious diseases of the cornea and conjunctiva, mycobacterial infections of the eye, or fungal diseases of ocular structures.
- people with ACIOL (Anterior Chamber Intraocular Lens) or rupture of the posterior lens capsule.
- Diagnosis of any form of glaucoma or ocular hypertension at screening, unless the study eye is being treated with ≤2 intraocular pressure (IOP)-lowering medications and/or has been previously treated with an incisional...
- Intraocular pressure \>21 mmHg or concurrent therapy at screening with \>2 IOP-lowering pharmacologic agents in the study eye.
- Any eye surgery within 12 weeks prior to Day 1 of the study.
- people who are unable to attend scheduled follow-up visits throughout the 12-month study.
- Has a significant media opacity precluding evaluation of retina and vitreous in the study eye.
The study team makes the final eligibility decision.
Where it's taking place
- Plano, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Plano, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.