UveitisPhase 3TYNINCT05486468
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
A Phase 3 study testing Yutiq 0.18 MG Drug Implant in people with Uveitis and Uveitis, Posterior, run by Texas Retina Associates at 1 site in United States.
Trial summary
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Uveitis, Posterior, Uveitis, Anterior
- What is being tested?
- Yutiq 0.18 MG Drug Implant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 31 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria:
- 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.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Ocular Inclusion Criteria (Study Eye):
- 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.
- Presence of active posterior segment inflammation as determined by the Investigator.
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- Vitreous haze grade ≥ 2 based on the standardization of uveitis nomenclature (SUN) criteria.
- Less than 10 anterior chamber cells/high power field determined by slit lamp examination.
- Not planning to undergo elective ocular surgery during the study.
Who cannot join
- General Exclusion Criteria:
- Subjects with known hypersensitivity to any components of YUTIQ.
- Female subjects who are pregnant or breastfeeding.
- 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):
- History of anterior uveitis only (without associated uveitis that affected the posterior segment).
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- Presence of a vitreous hemorrhage.
- Uveitis with infectious etiology.
- Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma).
- Current infectious diseases of the cornea and conjunctiva, mycobacterial infections of the eye, or fungal diseases of ocular structures.
- Subjects with ACIOL (Anterior Chamber Intraocular Lens) or rupture of the posterior lens capsule.
- 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).
- Intraocular pressure >21 mmHg or concurrent therapy at screening with >2 IOP-lowering pharmacologic agents in the study eye.
- Any eye surgery within 12 weeks prior to Day 1 of the study.
- Subjects who are unable to attend scheduled follow-up visits throughout the 12-month study.
- Has a significant media opacity precluding evaluation of retina and vitreous in the study eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
Read the detailed 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.
- Conditions
- Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate
- Being tested
- Yutiq 0.18 MG Drug Implant, Sham Injection
- Medical subject headings
- Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yutiq 0.18 MG Drug ImplantDrug
YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection
Sham InjectionOther
Sham injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | This group will receive two YUTIQ implants at day 1. Receives: Drug: Yutiq 0.18 MG Drug Implant |
| Control Arm | Sham comparator | This group will receive two sham injections at day 1. Receives: Other: Sham Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of uveitis will be assessed at the 6-month visit
The primary endpoint of recurrence rate of uveitis will be assessed at the 6-month visit. The clinical definition of intraocular inflammation recurrence is (1) 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), (2) a 2-step or more increase in vitreous haze, or (3) a deterioration in BCVA of 15 letters or more. In each case, the etiology of the change must be only due to noninfectious uveitis.
Measured: 6 months
Secondary outcomes (1)
Recurrence rate of uveitis at the 12-month visit
The secondary endpoints include determining the recurrence rate of uveitis at the 12-month visit, time to first uveitis recurrence, change in BCVA from baseline by ETDRS letters read at the 12-month visit, total number of necessary adjunctive treatments necessary, mean changes in CST as measured by SD-OCT, and mean changes from baseline in BCVA by ETDRS letters read. A final secondary endpoint will be to evaluate the changes in vascular leakage on FA, which will qualitatively be determined by the investigator.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start5 Oct 2022
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 year, prospective, randomized, collaborative study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Retina Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Eye Point Pharmaceuticals, ANI Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486468
- Sponsor's protocol ID
- TRA-TYNI-22-001
- Acronym
- TYNI
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
- ClinicalTrials.gov ID
- NCT05486468
- Acronym / sponsor ID
- TYNI / TRA-TYNI-22-001
- Conditions
- Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Texas Retina AssociatesUniversity, hospital or other
- Collaborators
- Eye Point Pharmaceuticals, ANI Pharmaceuticals
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 1 year, prospective, randomized, collaborative study.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Yutiq 0.18 MG Drug ImplantThis group will receive two YUTIQ implants at day 1. |
| Control Arm | Sham comparator | Other: Sham InjectionThis group will receive two sham injections at day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- 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.
- Presence of active posterior segment inflammation as determined by the Investigator.
- Vitreous haze grade ≥ 2 based on the standardization of uveitis nomenclature (SUN) criteria.
Key exclusion criteria (16 listed)
- Subjects with known hypersensitivity to any components of YUTIQ.
- Female subjects who are pregnant or breastfeeding.
- 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.
- History of anterior uveitis only (without associated uveitis that affected the posterior segment).
- Presence of a vitreous hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yutiq 0.18 MG Drug ImplantYUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection | Drug | Treatment Arm |
| Sham InjectionSham injection | Other | Control Arm |
Primary outcome
Recurrence rate of uveitis will be assessed at the 6-month visit
Time frame: 6 months
The primary endpoint of recurrence rate of uveitis will be assessed at the 6-month visit. The clinical definition of intraocular inflammation recurrence is (1) 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), (2) a 2-step or more increase in vitreous haze, or (3) a deterioration in BCVA of 15 letters or more. In each case, the etiology of the change must be only due to noninfectious uveitis.
1 secondary outcome
Recurrence rate of uveitis at the 12-month visit
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Yutiq 0.18 MG Drug Implant in people with Uveitis and Uveitis, Posterior, run by Texas Retina Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of uveitis will be assessed at the 6-month visit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.