Vogt-Koyanagi-Harada DiseaseNCT05627739
A Study of Mycophenolate Mofetil Combined With Glucocorticoid Therapy in Relapse Vogt-Koyanagi-Harada Disease
An observational study of Vogt-Koyanagi-Harada Disease and Mycophenolate Mofetil, run by Tianjin Medical University at 1 site in China.
Trial summary
This project is designed to test the hypothesis that Mycophenolate Mofetil is clinically useful for patients with relapse Vogt-Koyanagi-Harada disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vogt-Koyanagi-Harada Disease, Mycophenolate Mofetil
- What is being tested?
- Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: VKH patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital
Who may be able to join
- Subject is 18 to 70 years of age.
- Subjects who do not have previous, active or latent tuberculosis (TB).
- Subject must start Vogt-Koyanagi-Harada disease more than two months, and develop at least one recurrence.
Who cannot join
- Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
- Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
- Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy (except intravitreal anti-vascular endothelial growth factor [VEGF] therapy) with a potential therapeutic impact on non-infectious uveitis.
- Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
- Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
- Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
xiaomin Zhang
Tianjin, Tianjin Municipality, 300000
xiaomin Zhang, +8613920023990, xiaomzh@126.com
About this study
Official title: An Observational Study of Mycophenolate Mofetil Combined With Glucocorticoid in the Treatment of Relapse Vogt-Koyanagi-Harada Disease
This project is designed to test the hypothesis that Mycophenolate Mofetil is clinically useful for patients with relapse Vogt-Koyanagi-Harada disease
Read the 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 Mycophenolate Mofetil, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with relapse VKH divided into two groups: Mycophenolate Mofetil therapy group and traditional therapy group.
For Mycophenolate Mofetil therapy group, an initial dose of 0.5-1.0g bid MMF was orally administered every day, glucocorticoid was started at a dose of 0.5-0.8 mg/kg/day and no more than 60 mg/day. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine. Study participants will be followed for up to one year 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 immunosuppressive effects of MMF in treatment of relapse VKH.
- Being tested
- Mycophenolate Mofetil
- Medical subject headings
- Uveomeningoencephalitic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucocorticoid is started at a dose of 0.5-0.8 mg/kg/day, and 60 mg daily was the highest dose. Mycophenolate mofetilwas is started at a dose of 0.5-1.0g bid.
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate Mofetil therapy Group | An initial dose of 0.5-1.0g bid MMF was orally administered every day, glucocorticoid was started at a dose of 0.5-0.8 mg/kg/day and no more than 60 mg/day. Receives: Drug: Mycophenolate Mofetil | |
| traditional therapy group | Patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
The 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.
Measured: 24 weeks
Recurrence rate
The recurrence rates in Mycophenolate mofetil treatment group and control group
Measured: 24 weeks
Secondary outcomes (2)
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.
Measured: 24 weeks
Prednisone exposure
Cumulative prednisone dose and/or mean prednisone dose
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Oct 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 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 DiseaseStudies of the same condition, open and under way.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomin Zhang, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627739
- Sponsor's protocol ID
- 2022KY-28
- Status last verified
- Dec 2023
- First submitted
- 11 Nov 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Mycophenolate Mofetil Combined With Glucocorticoid in the Treatment of Relapse Vogt-Koyanagi-Harada Disease
- ClinicalTrials.gov ID
- NCT05627739
- Acronym / sponsor ID
- 2022KY-28
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Nov 2022 (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.
This project is designed to test the hypothesis that Mycophenolate Mofetil is clinically useful for patients with relapse Vogt-Koyanagi-Harada disease
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 Mycophenolate Mofetil, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with relapse VKH divided into two groups: Mycophenolate Mofetil therapy group and traditional therapy group.
For Mycophenolate Mofetil therapy group, an initial dose of 0.5-1.0g bid MMF was orally administered every day, glucocorticoid was started at a dose of 0.5-0.8 mg/kg/day and no more than 60 mg/day. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine. Study participants will be followed for up to one year 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 immunosuppressive effects of MMF in treatment of relapse VKH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate Mofetil therapy Group | – | Drug: Mycophenolate MofetilAn initial dose of 0.5-1.0g bid MMF was orally administered every day, glucocorticoid was started at a dose of 0.5-0.8 mg/kg/day and no more than 60 mg/day. |
| traditional therapy group | – | –Patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- VKH patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital
Key inclusion criteria (3 listed)
- Subject is 18 to 70 years of age.
- Subjects who do not have previous, active or latent tuberculosis (TB).
- Subject must start Vogt-Koyanagi-Harada disease more than two months, and develop at least one recurrence.
Key exclusion criteria (6 listed)
- Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
- Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
- Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy (except intravitreal anti-vascular endothelial growth factor [VEGF] therapy) with a potential therapeutic impact on non-infectious uveitis.
- Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
- Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
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 |
|---|---|---|
| Mycophenolate MofetilGlucocorticoid is started at a dose of 0.5-0.8 mg/kg/day, and 60 mg daily was the highest dose. Mycophenolate mofetilwas is started at a dose of 0.5-1.0g bid. | Drug | Mycophenolate Mofetil therapy Group |
Primary outcome
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
Time frame: 24 weeks
The 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.
Recurrence rate
Time frame: 24 weeks
The recurrence rates in Mycophenolate mofetil treatment group and control group
2 secondary outcomes
Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit
Time frame: 24 weeks
Prednisone exposure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
Related trials for Vogt-Koyanagi-Harada Disease
Recruiting
Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease
Vogt Koyanagi Harada Disease
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 and Mycophenolate Mofetil, run by Tianjin Medical 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 3 inclusion and 6 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 7 Dec 2023. 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 xiaomin Zhang (+8613920023990, xiaomzh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit. (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 7 Dec 2023.