Trials / Unknown
UnknownNCT04150770
A Clinical Trial of Infliximab for Childhood Uveitis
A Clinical Trial of Infliximab for Injection in Refractory Childhood Uveitis
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Xiaomin Zhang · Academic / Other
- Sex
- All
- Age
- 4 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
This project is designed to test the hypothesis that infliximab is clinically useful for patients with refractory childhood 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 study design, aims, and the off-label use of infliximab, its potential risks and benefits. This is a prospective non-comparative interventional study. Participants will receive intravitreal injections of suggested dose of infliximab (5 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 10 months to determine efficacy and side effects, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | infliximab |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2020-01-01
- Completion
- 2022-12-01
- First posted
- 2019-11-05
- Last updated
- 2021-11-02
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04150770. Inclusion in this directory is not an endorsement.