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This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| traditional therapy group | Patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants and were followed for up to 36 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yutiq | Drug | YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic non-infectious uveitis patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaomin Zhang | Contact | +8613920023990 | xiaomzh@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 12 months |
| Prednisone exposure | Cumulative prednisone dose and/or mean prednisone dose | 36 months |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |