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Corticosteroid
YUTIQ Injections for Uveitis (TYNI Trial)
Phase 3
Recruiting
Research Sponsored by Texas Retina Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
TYNI Trial Summary
This trial found that using two YUTIQ injections was more effective than a sham injection for treating chronic non-infectious intraocular inflammation.
Who is the study for?
Adults in good health with chronic noninfectious inflammation in the back part of the eye, who've responded to steroids before, can join. They must understand and sign consent forms, follow study rules, and not be planning eye surgery during the trial. Pregnant women or those with certain other eye conditions or high eye pressure are excluded.Check my eligibility
What is being tested?
The TYNI Trial is testing if two implants of a drug called YUTIQ are better than a fake treatment (sham) for long-term inflammation inside the eye that doesn't come from an infection. Participants will either get YUTIQ implants or sham injections to compare effectiveness.See study design
What are the potential side effects?
YUTIQ may cause increased pressure inside the eye, cataracts, temporary visual blurring after implantation, and possibly some discomfort at the injection site. The exact side effects experienced can vary between individuals.
TYNI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence rate of uveitis will be assessed at the 6-month visit
Secondary outcome measures
Uveitis
TYNI Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
This group will receive two YUTIQ implants at day 1.
Group II: Control ArmPlacebo Group1 Intervention
This group will receive two sham injections at day 1.
Find a Location
Who is running the clinical trial?
Texas Retina AssociatesLead Sponsor
5 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Uveitis
12 Patients Enrolled for Uveitis
Eye Point PharmaceuticalsUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had eye surgery in the last 3 months.I am not planning any eye surgery during the study.I have active inflammation in the back part of my eye.My eye inflammation is moderate to severe.I have bleeding inside my eye.I am willing and able to follow the study's schedule and procedures.My eye inflammation is not due to non-infectious uveitis.I am not pregnant or breastfeeding.I have had inflammation in the front part of my eye only.I do not have any current eye infections, including fungal or mycobacterial types.I have long-term eye inflammation that improved with steroids but came back.I have glaucoma or high eye pressure, treated with up to 2 medications or surgery, and my eye pressure is now 10-21 mmHg.My eye inflammation is caused by an infection.My eye pressure is over 21 mmHg or I use more than 2 medications to lower it.I am over 18, healthy, understand the consent form, and agree to sign it.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are possible adverse effects of the Yutiq 0.18 MG Drug Implant?
"Yutiq 0.18 MG Drug Implant is classified as a phase 3 medication, which means that while there is some evidence of its efficacy, multiple rounds of testing have confirmed its safety."
Answered by AI
Are people currently being recruited for this research project?
"Yes, the information on clinicaltrials.gov points out that this study is presently recruiting patients. The clinical trial was first posted on 10/5/2022 and was most recently edited on 10/27/2022. The clinical trial is enrolling 30 participants between 1 sites"
Answered by AI
What is the total sample size for this research project?
"That is correct. The clinicaltrials.gov website indicates that this research is actively recruiting patients. This trial was originally posted on October 5th, 2020 and edited most recently on October 27th, 2020. They are looking for a total of 30 people to participate at 1 location."
Answered by AI
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