RecruitingPhase 3

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

United States30 participantsStarted 2022-10-05

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Less than 10 anterior chamber cells/high power field determined by slit lamp examination.
✓. Not planning to undergo elective ocular surgery during the study.

✕. 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.

Recurrence rate of uveitis will be assessed at the 6-month visit

Timeframe: 6 months

NCT IDNCT05486468

SponsorTexas Retina Associates

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Tara Keesling, COA

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Less than 10 anterior chamber cells/high power field determined by slit lamp examination.
✓. Not planning to undergo elective ocular surgery during the study.

✕. 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.