A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis

NCT05592717 | Recruiting

• 1 other identifier: 2022KY-17
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.

Conditions

Uveitis; YUTIQ

Outcome Measures

Primary Outcomes (2)

• Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.

  Participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.

  12 months

• Recurrence rates

  The recurrence rates in Yutiq group and traditional therapy group

  36 months

Secondary Outcomes (2)

• Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit

  12 months

• Prednisone exposure

  36 months

Study Arms (2)

Yutiq group

Patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye and will be followed for 36 months after treatment.

Drug: Yutiq

traditional therapy group

Patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants and were followed for up to 36 months.

Interventions

Yutiq DRUG

YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.

Yutiq group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic non-infectious uveitis patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital

You may qualify if:

• Male or female in good general health at 18 to 70 years of age.
• Presence of unilateral or bilateral non-infectious uveitis affecting the posterior segment
• Patients have active inflammation before Yutiq treatment. Subject meets at least 1 of the following criteria: 1. ≥1+ anterior chamber cell and/or ≥1+ vitreous haze. 2. Fluorescein angiography demonstrates leakages. 3. OCT images showing the macular edema. 4. The times of relapse in one year are equal to or greater than 3.
• Steroids and immunosuppressive agents were discontinued within 3 months after Yutiq injection.

You may not qualify if:

• Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
• Subject with a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
• Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1.
• Prior intravitreal treatment with OZURDEX® within 12 weeks prior to Day 1. Prior intravitreal treatment with Triesence® or TRIVARIS™ (triamcinolone) within 12 weeks prior to Day 1.
• Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.
• Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage).
• Hypersensitivity to any of the ingredients contained in YUTIQ®.
• Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
• Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to Day 1 until the final study visit.

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Uveitis

Interventions

Fluocinolone Acetonide

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

xiaomin Zhang

CONTACT

+8613920023990; xiaomzh@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 25, 2022
• Study Start: January 5, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

CN (1)