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

Uveitis Clinical Trial

Official title:

An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592717
• Other study ID #: 2022KY-17
• Status: Recruiting
• Start date: January 5, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: April 2023
• Source: Tianjin Medical University
• Contact: xiaomin Zhang
• Phone: +8613920023990
• Email: xiaomzh[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of Yutiq, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with chronic non-infectious uveitis divided into two groups: Yutiq therapy group and traditional therapy group. For Yutiq therapy group, patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants. Study participants will be followed for up to 3 years to determine efficacy and side effects. According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and reducing relapses effects of Yutiq in treatment of chronic non-infectious uveitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or female in good general health at 18 to 70 years of age.

2. Presence of unilateral or bilateral non-infectious uveitis affecting the posterior segment

3. 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.

4. Steroids and immunosuppressive agents were discontinued within 3 months after Yutiq injection.

Exclusion Criteria:

1. Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.

2. Subject with a history of neurologic symptoms suggestive of central nervous system demyelinating disease.

3. Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1.

4. 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.

5. Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.

6. Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage).

7. Hypersensitivity to any of the ingredients contained in YUTIQ®.

8. Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.

9. 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.

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• Yutiq
YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.

Locations

Country	Name	City	State
China	Tianjin Medical University Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recurrence rates	The recurrence rates in Yutiq group and traditional therapy group	36 months
Secondary	Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit	Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0 = < 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = > 50 cells.	12 months
Secondary	Prednisone exposure	Cumulative prednisone dose and/or mean prednisone dose	36 months