Skip to content

Methylprednisolone plus cyclophosphamide in thyroid associated ophthalmopathy

A prospective, randomized trial of intravenous methylprednisolone plus cyclophosphamide pulse therapy for thyroid associated ophthalmopathy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17010472
Enrollment
Unknown
Registered
2017-01-19
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

thyroid associated ophthalmopathy

Interventions

I:Cyclophosphamide+methylprednisolone
II:Methylprednisolone

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 20 to 60 Years male and female; 2) Euthyroid for at least 3 months; 3) Moderate to severe and active thyroid associated ophthalmopathy; 4) Not been treated for their orbitopathy except for local measures; 5) Not been treated with radioioding or thyroidextomy; 6) Gave their informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1) History of HIV, hepatitis C or hepatitis B Positive, and chronic recurrent or active infection; 2) History of peptic ulcer within 3 months; 3) History of malignant tumor; 4) Uncontrolled diabetes mellitus; 5) Chronic obstructive pulmonary disease, or asthma treated with oral glucocorticoids; 6) Patients with a history of chronic liver disease or liver disorders, ALT or AST above 2.5 times upper limit of normal; 7) Uncontrolled hypertension; 8) Cardiovascular or cerebrovascular disease clinically significant; 9) Combined with ophthalmological signs caused by other diseases; 10) Underhone ophthalmic aurgery within 3 months; 11) Use of corticosteroids and other immunosuppressive agents during 12 weeks before to inclusion period, or with systematic diseases treated with corticosteroids and other immunosuppressive agents; 12) Pregnant patient or patient who is planning to become pregnant during the study; 13) Allergic to cyclophosphamide or methylprednisolone.

Design outcomes

Primary

MeasureTime frame
Response;hemorrhagic cystitis;

Secondary

MeasureTime frame
Deterioration;GO-QoL;NOSPECS;CAS;proptosis;lid width;diplopia;IOP;??;

Countries

China

Contacts

Public ContactJin-Wei Cheng

Shanghai Changzheng Hospital

jinnwave@163.com+86 021-81886819

Outcome results

None listed

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