Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05486468
Status:
RECRUITING
Last Update Posted:
2022-10-31
First Post:
2022-08-01
Brief Title:
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
Sponsor:
Texas Retina Associates
Organization:
Texas Retina Associates
Study Overview
Official Title:
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment TYNI Trial
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TYNI
Brief Summary:
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment TYNI Trial
Detailed Description:
10 RATIONALE AND NEEDS ASSESSMENT Primary Eyepoint Drugs YUTIQ
Study Rationale
The current data shows that in eyes from patients with chronic non-infectious posterior uveitisNIPU 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 x16 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 Rationale
The current data shows that in eyes from patients with chronic non-infectious posterior uveitisNIPU 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 x16 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None