YUTIQ Injections for Uveitis
(TYNI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines YUTIQ, a small drug implant, to assess its effectiveness for individuals with chronic non-infectious uveitis, an eye inflammation affecting the back of the eye. The trial compares two groups: one receiving YUTIQ implants and the other receiving a placebo to observe differences in effects. Suitable candidates for this trial have ongoing eye inflammation that previously responded to steroids but recurs. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the YUTIQ trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that YUTIQ, a small implant that releases medication, is generally safe and effective for treating non-infectious uveitis, a type of eye inflammation. In previous studies, patients who received the 0.18 mg implant experienced a significant decrease in eye inflammation and swelling, with little need for additional steroid treatments. The U.S. Food and Drug Administration (FDA) approved YUTIQ for this condition, indicating a strong safety record. Always consult your healthcare provider for personalized advice.12345
Why do researchers think this study treatment might be promising for uveitis?
Unlike the standard treatments for uveitis, which often involve oral or topical corticosteroids and immunosuppressive drugs, YUTIQ offers a unique approach with its 0.18 MG drug implant. This implant delivers a continuous, low-dose release of fluocinolone acetonide directly to the eye, potentially reducing the need for frequent dosing and minimizing systemic side effects. Researchers are excited about YUTIQ because it targets inflammation at the source and provides long-term control of uveitis symptoms, which could lead to better patient outcomes and improved quality of life.
What evidence suggests that YUTIQ might be an effective treatment for uveitis?
Research has shown that the YUTIQ 0.18 mg drug implant effectively treats chronic non-infectious uveitis, a type of eye inflammation. In this trial, participants in the treatment arm will receive two YUTIQ implants. Studies have found that this implant helps prevent inflammation recurrence and reduces the need for additional eye injections. While effective as part of a treatment plan, it might not suffice for everyone on its own. Overall, YUTIQ has demonstrated promising results in managing this condition.36789
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two YUTIQ implants or two sham injections at day 1
Follow-up
Participants are monitored for recurrence rate of uveitis and other secondary outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Sham Injection
- Yutiq 0.18 MG Drug Implant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Texas Retina Associates
Lead Sponsor
ANI Pharmaceuticals
Industry Sponsor
Eye Point Pharmaceuticals
Collaborator