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

Phase 4

Withdrawn

Conditions: Graves' Orbitopathy
Swelling behind the eyes from Graves' disease
10042261

Registration Number: NL-OMON47457

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 130

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 < 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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures