Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH
NCT ID: NCT05120687
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2021-10-15
2025-10-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Noncorticosteroid systemic immunomodulatory therapy (NCSIT) demonstrated inflammation control and steroid-sparing effect in autoimmune diseases. Methotrexate as an antifolate metabolite has been widely used for its anti-inflammatory and immunomodulating properties. Adalimumab, humanized monoclonal anti-TNF-α antibody, have demonstrated the efficacy of noninfectious uveitis. Several randomized controlled trials have proved the efficacy and safety of NCSIT such as antimetabolite and biologics in non-infectious uveitis, while the optimal dose and treatment course remain unknown.
The investigators propose to explore the effect, safety and optimal dose of prednisone combining NCSIT in the treatment of VKH.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Corticosteroid group
Patients in corticosteroid group will receive systemic corticosteroid. In case of severe, the patients may receive methylprednisolone (no more than 1 gram/day) followed by gradual taper of oral prednisone.
No interventions assigned to this group
Corticosteroid + NCSIT group
Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate or Adalimumab or other noncorticosteroid systemic immunomodulatory such as cyclophosphamide.
noncorticosteroid systemic immunomodulatory therapy (NCSIT)
Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate 15mg/week or Adalimumab 40mg /2weeks or Mycophenolate Mofetil 1g/day or Cyclosporin 50mg-100mg/day or cyclophosphamide 10mg/kg on two consecutive days every 2 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
noncorticosteroid systemic immunomodulatory therapy (NCSIT)
Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate 15mg/week or Adalimumab 40mg /2weeks or Mycophenolate Mofetil 1g/day or Cyclosporin 50mg-100mg/day or cyclophosphamide 10mg/kg on two consecutive days every 2 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age from 12 to 70 years old.
* Patients have no contraindication of prednisone and immunosuppressive therapy, as determined by the investigator based on the results of laboratory and physical examinations.
* Written informed consent is provided.
Exclusion Criteria
* History of renal or hepatic insufficiency, heart failure, systemic inflammatory disease or any other condition that, in the opinion of the investigator, would put the patients at risk by participating in the protocol.
* History of infectious disease like chronic or active hepatitis B infection, HIV infection, immunodeficiency syndrome, chronic recurring infections, or active tuberculosis.
* Female patients who were pregnant or considering becoming pregnant during the study.
12 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dan Liang
Lab of ocular immunology in Zhongshan Ophthalmic Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Dan Liang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021NCSIT-VKH
Identifier Type: -
Identifier Source: org_study_id