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Methylprednisolone plus radiotherapy versus methylprednisolone plus mycophenolate in active moderate severely thyroid associated ophthalmopathy: a pilot study

Methylprednisolone plus radiotherapy versus methylprednisolone plus mycophenolate in active moderate severely thyroid associated ophthalmopathy: a pilot study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022212
Enrollment
Unknown
Registered
2019-03-30
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thyroid associated ophthalmopathy

Interventions

MR:ivMP 12 week in total 4.5g followed by 20Gy radiaotherapy
MM:ivMP in total 4.5g with mycophenolate 1g per day in 12 week

Sponsors

The Third Affiliated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Match Bartley Criteria; 2. Aged 20 to 65 years, all gender can be recruited; 3. The severity of TAO is moderate to severe based on the standard of EUGOGO; 4. The activity of TAO should at least match 3 items mentioned; 5. Female volunteers agree to contraception during the trial or have fertility requirement.

Exclusion criteria

Exclusion criteria: 1. TAO patients with other eye diseases; 2. TAO patients with threatening vision stage; 3. The original eye lesions such as hypertensive eye disease or diabetic retinopathy, glaucoma, etc.; 4. Those who have undergone orbital decompression or internal eye, ocular surface surgery, ocular trauma or ocular surface disease; 5. Suffering from other autoimmune diseases, acute and chronic infectious diseases; 6. Heart, liver, kidney function (previous) patients with incomplete; Heart function NYHA grade 3 or above; liver function alanine aminotransferase or aspartate aminotransferase is more than 3 times; urine routine urine protein (+++) or above, urine creatinine exceeds the normal reference range; 7. There are uncontrolled hypertension (grade 3 or above) and diabetes (glycated hemoglobin 8.0% or random blood glucose greater than 11.0mmol / L); 8. The cumulative dose of glucocorticoids used in the past 3 months is more than 1.5g (based on methylprednisolone); 9. (previously) have a history of peptic ulcer, bleeding, and a history of mental illness; 10. Special occupations, their working environment has obvious air pollution; 11. In the lactation period.

Design outcomes

Primary

MeasureTime frame
Treatment response rate;

Secondary

MeasureTime frame
QOL;psychological situation;General situation;routine blood test;routine urine test;liver function;kidney function;thyroid function;lipid function;ion test in blood;ACTH;BMD;ECG;14-C expiration test;MRI;COR;

Countries

China

Contacts

Public ContactLi Zhangfang
leecandy520@163.com+86 13427525514

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026