Trials / Recruiting
RecruitingNCT05592717
A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis
An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (estimated)
- Sponsor
- Tianjin Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- —
Summary
This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Yutiq | YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye. |
Timeline
- Start date
- 2023-01-05
- Primary completion
- 2025-11-01
- Completion
- 2026-11-01
- First posted
- 2022-10-25
- Last updated
- 2024-07-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05592717. Inclusion in this directory is not an endorsement.