Vogt Koyanagi Harada Disease (VKH)NCT05120687
Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH
An observational study of Vogt Koyanagi Harada Disease (VKH), run by Sun Yat-sen University at 1 site in China.
Trial summary
The aim of this study is to evaluate the efficacy and safety of corticosteroidcombining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH). Read more about this study
- Who is it for?
- Ages 12 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vogt Koyanagi Harada Disease (VKH)
- What is being tested?
- noncorticosteroid systemic immunomodulatory therapy (NCSIT)
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2021to 6 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: VKH patients treated at Zhongshan Ophthalmic Center between October 2021 and October 2025.
Who may be able to join
- Diagnosis is based on Revised International Diagnostic Criteria (Read et al. 2001b).
- 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.
Who cannot join
- Patients with other ocular diseases or fundus diseases: diabetic retinopathy, neovascular/wet age-related macular degeneration
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong
Dan Liang, （86）-87330402, liangdan@gzzoc.com
About this study
Official title: The Efficacy and Safety of Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH
The aim of this study is to evaluate the efficacy and safety of corticosteroidcombining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH).
Read the detailed description
Vogt Koyanagi Harada disease (VKH) is a sort of autoimmune disease directed against uveal melanocytes, which is a common vision-threatening noninfectious uveitis in colored people. VKH patients given prednisone monotherapy are prone to relapse.
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
- Vogt Koyanagi Harada Disease (VKH)
- Being tested
- noncorticosteroid systemic immunomodulatory therapy (NCSIT)
- Medical subject headings
- Uveomeningoencephalitic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noncorticosteroid systemic immunomodulatory therapy (NCSIT)Drug
Also called Methotrexate, Adalimumab, cyclophosphamide, Cyclosporin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. Receives: Drug: noncorticosteroid systemic immunomodulatory therapy (NCSIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants achieving corticosteroid-sparing effect
Corticosteroid-sparing effect is defined by the following: (1) less than or equal to 0.5+ anterior chamber cells, less than or equal to 0.5+ vitreous haze and no active retinal or choroidal lesions; (2) no more than 10 mg of oral prednisone per day; (3) all the above-mentioned description should be maintained over 1 month
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start15 Oct 2021
- Primary completion6 Oct 2024 (estimated)
- Study completion6 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vogt Koyanagi Harada Disease (VKH)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Liang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120687
- Sponsor's protocol ID
- 2021NCSIT-VKH
- Status last verified
- Nov 2021
- First submitted
- 15 Oct 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The aim of this study is to evaluate the efficacy and safety of prednisone combining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH).
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH
- ClinicalTrials.gov ID
- NCT05120687
- Acronym / sponsor ID
- 2021NCSIT-VKH
- Conditions
- Vogt Koyanagi Harada Disease (VKH)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 6 Oct 2024 (estimated)
- Study completion
- 6 Oct 2025 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy and safety of corticosteroidcombining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH).
Detailed description
Vogt Koyanagi Harada disease (VKH) is a sort of autoimmune disease directed against uveal melanocytes, which is a common vision-threatening noninfectious uveitis in colored people. VKH patients given prednisone monotherapy are prone to relapse.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Corticosteroid + NCSIT group | – | Drug: noncorticosteroid systemic immunomodulatory therapy (NCSIT)Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate or Adalimumab or other noncorticosteroid systemic immunomodulatory such as cyclophosphamide. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- VKH patients treated at Zhongshan Ophthalmic Center between October 2021 and October 2025.
Key inclusion criteria (4 listed)
- Diagnosis is based on Revised International Diagnostic Criteria (Read et al. 2001b).
- 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.
Key exclusion criteria (4 listed)
- Patients with other ocular diseases or fundus diseases: diabetic retinopathy, neovascular/wet age-related macular degeneration
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noncorticosteroid systemic immunomodulatory therapy (NCSIT)Also: Methotrexate, Adalimumab, cyclophosphamide, CyclosporinPatients 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. | Drug | Corticosteroid + NCSIT group |
Primary outcome
Number of participants achieving corticosteroid-sparing effect
Time frame: 6 months
Corticosteroid-sparing effect is defined by the following: (1) less than or equal to 0.5+ anterior chamber cells, less than or equal to 0.5+ vitreous haze and no active retinal or choroidal lesions; (2) no more than 10 mg of oral prednisone per day; (3) all the above-mentioned description should be maintained over 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: No. The aim of this study is to evaluate the efficacy and safety of prednisone combining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vogt Koyanagi Harada Disease (VKH), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Liang (#86#-87330402, liangdan@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving corticosteroid-sparing effect (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.