Methylprednisolon Pulse Therapy vs Methylprednisolon Pulse Therapy combined with Radiotherapy for Moderately Severe and Active Graves* Orbitopathy - PULSERAT

Academisch Medisch Centrum0 个研究点目标入组 130 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•1. Active Graves' Orbitopathy (GO):
•- onset less than 12 months, and
•- CAS * 3 out of 7 or 4 out of 10
•2. Moderately severe GO:
•- NOSPECS grade 2b or c, and/or
•- Severe proptosis (in women * 20mm and in men * 22 mm), and/or
•- Motility restriction defined as a duction < 30 degrees in either abduction, adduction, elevation or depression, and/or
•- Gorman/Bahn score of C (Gorman/Bahn score: A.no diplopia; B. intermittent; C. inconstant; D: constant)
•3. Clinically and biochemically euthyroidism for at least 6 weeks

•1. Unable or unwilling to provide informed consent
•2. Age <35 years or >75
•3. Diabetes mellitus
•4. Mild GO
•5. Presence of dysthyroid optic neuropathy (DON)
•6. Previous orbital surgery or radiotherapy for GO.
•7. Corticosteroid or immunotherapy (on average > 20mg daily) for GO within previous 3 months
•8. Pre-existent strabismus
•9. Patients with amblyopia or with functional monocular vision making it impossible to measure diplopia and/or strabismus
•10. Patients with pre existent glaucoma with severe visual field defects
•11. Pregnancy
•12. Unfit for corticosteroid therapy as decided by endocrinologist
•13. Abnormal liver function (factor 2 above normal values)

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