The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment

Launched by TEXAS RETINA ASSOCIATES · Aug 2, 2022

Keywords

ClinConnect Summary

This clinical trial, called the TYNI Trial, is investigating the effectiveness of a treatment called YUTIQ for people suffering from chronic non-infectious inflammation in the back part of the eye, known as uveitis. The trial is comparing the use of two YUTIQ treatments against a placebo (an inactive treatment) to see which is more effective in reducing inflammation. Participants must be at least 18 years old and in good general health, with a specific diagnosis of chronic eye inflammation that has not responded well to previous steroid treatments.

If you or a loved one are considering joining this study, it's important to know that you would need to attend regular visits and follow a specific treatment plan for up to 12 months. To be eligible, you should not have any serious eye conditions or infections, and you should not be pregnant or breastfeeding. The trial aims to help improve treatment options for chronic uveitis, so your participation could contribute to important advancements in eye health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• General Inclusion Criteria:
• • 1. 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 information release (HIPAA form) before any study procedures are performed.
• • 2. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Ocular Inclusion Criteria (Study Eye):
• • 1. 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 localized type (eg, topical steroid 2 to 4 times per day or intra- or peri-ocular injection) or systemic corticosteroid/immunosuppressant treatment with recurrence following treatment indicating chronicity according to the Investigator's judgment.
• • 2. Presence of active posterior segment inflammation as determined by the Investigator.
• • 3. Vitreous haze grade ≥ 2 based on the standardization of uveitis nomenclature (SUN) criteria.
• • 4. Less than 10 anterior chamber cells/high power field determined by slit lamp examination.
• • 5. Not planning to undergo elective ocular surgery during the study.
• Exclusion Criteria:
• General Exclusion Criteria:
• • 1. Subjects with known hypersensitivity to any components of YUTIQ.
• • 2. Female subjects who are pregnant or breastfeeding.
• • 3. 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.
• Ocular Exclusion Criteria (Study Eye):
• • 1. History of anterior uveitis only (without associated uveitis that affected the posterior segment).
• • 2. Presence of a vitreous hemorrhage.
• • 3. Uveitis with infectious etiology.
• • 4. Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma).
• • 5. Current infectious diseases of the cornea and conjunctiva, mycobacterial infections of the eye, or fungal diseases of ocular structures.
• • 6. Subjects with ACIOL (Anterior Chamber Intraocular Lens) or rupture of the posterior lens capsule.
• • 7. 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 surgical procedure resulting in stable IOP in the normal range (10 to 21 mmHg).
• • 8. Intraocular pressure \>21 mmHg or concurrent therapy at screening with \>2 IOP-lowering pharmacologic agents in the study eye.
• • 9. Any eye surgery within 12 weeks prior to Day 1 of the study.
• • 10. Subjects who are unable to attend scheduled follow-up visits throughout the 12-month study.
• • 11. Has a significant media opacity precluding evaluation of retina and vitreous in the study eye.