Background
Medical problem
Aim of the study
Methods/design
Objective of the study
Trial population
Clinical sites
Eligibility
Inclusion criteria | Exclusion criteria |
---|---|
• GD and GO onset ≤ 12 months • No previous GD treatment other than ATD • First relapse after decrease of antithyroid medication within 4–6 months • GO treatment with glucocorticoids based on the Kahaly scheme • Patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO • Clinically active inflammation according to CAScore (≥ 3/7) • Informed consent | • GD and GO onset ≥ 12 months • More than one relapse of GO longer than 6 months from diagnosis • Previous GD treatment by RAI or surgery • SNI greater than 7.0 • Urgent orbital decompression surgery • Loss of vision • Loss of visual field • Loss of color vision • Patients not receiving glucocorticoids for GO • Cytological findings of postsurgical histopathological results suspicious for malignancy • Pregnancy or breastfeeding • Contraindication to GC • Halt of GC therapy • Patients with diabetes mellitus • Age below 18 years • No informed consent |
Consent
Procedures for blinding and minimizing bias
Interventions
Pre-treatment interventions
Normal MI: | < 5.0 | |
Mild Graves’ orbitopathy | 4.5–5.5 | Grade I |
Moderate Graves’ orbitopathy | 5.5–6.5 | Grade II |
Severe Graves’ orbitopathy | > 6.5 | Grade III |
Normal SNI | < 5.75 | |
Danger for optic nerve compression | > 7.0 | Grade IV |
Kahaly scheme
Surgical intervention: thyroidectomy
Drug intervention: ATD
Post-treatment interventions
Initial screening until randomization | |||||||
---|---|---|---|---|---|---|---|
Day 1 (initial screening) | Day 2 (4–8 weeks after day 1) | Day 3 (4–8 weeks after day 2) | Day 4 (4–8 weeks after ATD reduction) | Day 5 (12–16 weeks after ATD reduction) | Day 6 (20–24 weeks after ATD reduction | ||
Pregnancy test | X | X | X | X | X | X | Randomization and treatment |
Blood tests | X | X | X | X | X | X | |
Slit-lamp bimicroscopy | X | X | |||||
Indirect fundoscopy | X | X | |||||
Visual acuity determination with Snellen test | X | X | |||||
Hertel exophthalmometry | X | X | |||||
Ocular motility, cover test, prism cover test, convergence | X | X | |||||
CAScore/NOSPECS | X | X | |||||
Ultrasound | X | ||||||
Adverse events | X | X | X | X | X | ||
Quality of life form | X | ||||||
Case report form | X | X | X | X | X | X | |
Blood parameter form | X | X | X | X | X | X | |
Current medication form | X | X | X | X | X | X | |
Eye examination form | X | X |
Follow-up schedule | ||||
---|---|---|---|---|
Follow-up 1 (8 weeks following treatment) | Follow-up 2 (16 weeks following treatment) | Follow-up 3 (32 weeks following treatment) | Follow-up 4 (1 year following treatment) | |
Pregnancy test | X | X | X | X |
Blood test | X | X | X | X |
Slit-lamp bimicroscopy | X | X | X | |
Indirect fundoscopy | X | X | X | |
Visual acuity determination with Snellen test | X | X | X | |
Hertel exophthalmometry | X | X | X | |
Ocular motility, cover test, prism cover test, convergence | X | X | X | |
CAScore/NOSPECS | X | X | X | |
Ultrasound | X | |||
Adverse events | X | X | X | X |
Quality of life form | X | |||
Case report form | X | X | X | X |
Blood parameter form | X | X | X | X |
Current medication form | X | X | X | X |
Eye examination form | X | X | X |