A post-marketing study in Real-World of Fluocinolone Acetonide Intravitreal Insert in Patients With Chronic Noninfectious Uveitis Affecting the Posterior Segment of the Eye

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400091284

Enrollment

Unknown

Registered

2024-10-24

Start date

2023-12-21

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Noninfectious Uveitis Affecting the Posterior Segment of the Eye

Interventions

FIA Injection group:NA

Eligibility

Sex/Gender

All

Age

12 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) The subjects voluntarily participate in the study; 2) Diagnosed with unilateral or bilateral chronic NIU-PS

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity to FA or any component of the FAI insert; 2) Ocular or periocular infectious diseases; 3) Pregnant or breastfeeding females; all subjects of childbearing potential (male andfemale) who are unwilling or unable to use acceptable methods of contraception as defined in this protocol

Design outcomes

Primary

Measure	Time frame
In FAI insert group, study eye BCVA changes at months 3 after injection from baseline;In FAI insert group, compare the uveitis recurrence rate within 6 months before and after FAI insert injection in the study eye;	—

Secondary

Measure	Time frame
In FAI insert group, change from baseline in BCVA after FAI insert injection in study eye (Months 6, 12, and 36);In FAI insert group, change in systematic hormone therapy dose from baseline (Months 6, 12, and 36);In FAI insert group, determination of macular edema by OCT compared to baseline(Months 6, 12, and 36);roportion of subjects who have recurrence of uveitis in the study eye compared with external control group (Months 6, 12 and 36);Time to first recurrence of uveitis compared to the external control group;Mean change from baseline in BCVA compared to the external control group (Months 6, 12, and 36);Change in systematic hormone therapy dose compared to the external control group (Months 6, 12, and 36);Resolution of macular edema measured by OCT imaging compared to the external control group (Months 6, 12, and 36);	—

Measure

Time frame

In FAI insert group, change from baseline in BCVA after FAI insert injection in study eye (Months 6, 12, and 36);In FAI insert group, change in systematic hormone therapy dose from baseline (Months 6, 12, and 36);In FAI insert group, determination of macular edema by OCT compared to baseline(Months 6, 12, and 36);roportion of subjects who have recurrence of uveitis in the study eye compared with external control group (Months 6, 12 and 36);Time to first recurrence of uveitis compared to the external control group;Mean change from baseline in BCVA compared to the external control group (Months 6, 12, and 36);Change in systematic hormone therapy dose compared to the external control group (Months 6, 12, and 36);Resolution of macular edema measured by OCT imaging compared to the external control group (Months 6, 12, and 36);

—

Countries

China

Contacts

Public ContactXiaomin Zhang

Tianjin Medical University Eye Hospital

xiaomzh@126.com+86 139 2002 3990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026