Uveitis Clinical Trial - The Use of Two YUTIQ Versus Sham for Treatment of

Status Recruiting

Clinical Trial Summary

The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)

Clinical Trial Description

1.0 RATIONALE AND NEEDS ASSESSMENT Primary Eyepoint Drug(s): YUTIQ Study Rationale: The current data shows that in eyes from patients with chronic non-infectious posterior uveitis(NIPU), a single YUTIQ implant decreases the number of uveitis recurrences, led to less necessary adjunctive treatments, demonstrated less visual acuity loss, and had an acceptable side effect profile. Naturally, we asked whether two YUTIQ implants at the time of treatment would lead to an improved level of control of intraocular inflammation. We propose to evaluate the safety and efficacy of two YUTIQ implants versus two sham injections to manage inflammation associated with NIPU. Needs Assessment: Chronic noninfectious uveitis of the posterior segment of the eye is a visually debilitating disease to patients affected with it. Untreated or undertreated recurrent episodes of inflammation in these patients lead to permanent damage to the intraocular structures of the eye resulting in irreversible vision loss. Recent data has shown that a single YUTIQ implant demonstrated an improved level of control of intraocular inflammation, decreased frequency of uveitis flare ups, and led to less visual acuity loss compared to sham. However, there were still patients in the treatment group who had suboptimal control of their intraocular inflammation, experienced uveitis flares, and had a decrease in best-corrected visual acuity (BCVA). A study evaluating two YUTIQ implants for chronic NIPU would provide data to address whether this treatment paradigm would lead to superior outcomes and reduced treatment burden. There are currently no published prospective trials that have evaluated primary therapy with two YUTIQ implants. In this study, we aim to compare the recurrence rate of uveitis by month 6 of two YUTIQ intravitreal implants to sha m. The clinical definition of intraocular inflammation recurrence is ( a 2 step or more increase in number of cells in the anterior chamber per high powered field (x1.6 using a 1 mm beam), ( a 2 step or more increase in vitreous haze, or ( a deterioration in BCVA of 15 letters or more. We expect a decreased rate of uveitis recurrences compared to sham. We also expect a decrease in inflammatory recurrences and increased time to first recurrence compared to prior data evaluating the use of a single YUTI Q implant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05486468
Study type	Interventional
Source	Texas Retina Associates
Contact	Tara Keesling, COA
Phone	9725969222
Email	tkeesling@texasretina.com
Status	Recruiting
Phase	Phase 3
Start date	October 5, 2022
Completion date	December 2024

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See also
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Active, not recruiting	`NCT05385757` - UNICORNS: Uveitis in Childhood Prospective National Cohort Study
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms