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

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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47457
Enrollment
130
Registered
2018-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Graves' Orbitopathy

Interventions

One group receives both iv CS and XRT, the other only iv CS
Graves' Orbitopathy
Prednisolone
Radiotherapy

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. Unable or unwilling to provide informed consent 2. Age 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)

Design outcomes

Primary

MeasureTime frame
1. Change in vertical lid aperture * 2mm 2. Change in NOSPECS grade 2 with 2 degrees (e.g. 2c to 2a) 3. Change in proptosis * 2 mm 4. Change in (any) duction * 8 degrees 5. Change in Gorman score * 1 level 6. Change in CAS * 2 points Endpoints are defined as: Improvement: change of * 2 parameters in at least one eye, without deterioration of any parameter in the contralateral eye Deterioration: deterioration in * 2 parameters in one or both eyes or development of new onset DON Unchanged: no changes or change in any of the parameters smaller than defined above—

Secondary

MeasureTime frame
1. Change of Goldmann field of BSV at 6 and 12 months 2. Change of GO-QOL at 6 and 12 months—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)