Thyroid Eye disease
Conditions
Interventions
Group 1:6-weekly 500mg, then 6-weekly 250mg IVPMP, 24-week oral mycophenolate sodium and sham radiotherapy
Group 2:6-weekly 500mg, then 6-weekly 250mg IVMP, 24-week oral Sirolimus, 10 sessions sham ORT
Group 3:6-weekly 500mg, then 6-weekly 250mg IVMP, 24-week oral placebo, 10 sessions 20-Gray ORT
Sponsors
Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Clinical diagnosis of progressive TED with onset = 2 (0=nil, 1= gaze, 2=intermittent primary, 3=constant primary, corrected by prism or abnormal head posture, 4= intractable primary) • Unselected CAS, further defined as low =3/7 • Restricted EOM movement to = 1 EOM enlarged on T1W sequence, increased water signal on STIR explaining clinical pattern of restrictive myopathy
Exclusion criteria
Exclusion criteria: • Age 75 • Unable or unwilling to provide informed consent or to comply with follow-up • Compressive optic neuropathy (EUGOGO criteria) • Concurrent orbital disorders • History or concurrent strabismus surgeries • Use of immunosuppressive agents/ RT • Subjects with known interocular suppression and/ or vision 2×reference range, recent( 8%) or uncontrolled hypertension (BP>160/100 mmHg), active peptic ulcer disease(PUD), and sepsis. • Complications or contraindications to ORT(Age <35, diabetic or hypertensive retinopathy, history of orbital radiotherapy) • Complications or contraindications to Sirolimus(hypersensitivity, immunosuppressed, active infection, history or actively treated lymphoma, progressive multifocal leukoencephalopathy, impaired or delayed wound healing). • Current drug or alcohol abuse, or history of either within the previous 2 years • Recent live vaccinations(including MMR, oral polio, BCG, yellow fever, varicella, TY21a typhoid), active Influenza and Pneumococcal vaccines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome (response rate) will be the proportion of patients achieving excellent-to-good versus no-change-or-worsened pCEMO at week 48.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include trend and predictive value of individual parameters, disease- and treatment-related complications. ; | — |
Countries
China
Contacts
Public ContactDr CHAN Kar Wun Karen
Department of Ophthalmology and Visual Sciences, PWH
Outcome results
None listed