Thyroid Associated Ophthalmopathy Clinical Trial
Official title:
A Phase IV, Randomized, Multi-center Clinical Trial to Compare the Efficacy of Orbital Radiotherapy in Association With Intravenous Glucocorticoids vs Intravenous Glucocorticoids Alone for Moderately Severe and Active Graves' Orbitopathy
Graves' orbitopathy (GO) is a disfiguring and disabling disease that profoundly impairs the quality of life of affected patients. High dose intravenous (iv) glucocorticoids (GC) (ivGC) is a well established, widely used treatment for active GO. The use of systemic glucocorticoids takes advantage from their immune suppressive and antiinflammatory actions, resulting in an overall beneficial effect ranging from ~35 to ~60% of patients in various studies. The intravenous route of administration has been shown to be superior to the oral route, both in terms of GO outcome and side effect profile. The combination of ivGC and orbital radiotherapy (OR) is used routinely in patients with moderate-severe, active GO, as a second-line treatment, as also recommended in the recent Guidelines published by the European Thyroid Association/European Group on Graves' Orbitopathy. Thus, the majority of studies have shown that OR increases the response rate to GC. Those studies were performed using oral GC, whereas it is not known whether OR potentiate also the effects of ivGC. The present study is aimed at determining whether OR potentiate the effects of ivGC in the treatment of moderately severe and active GO, in terms of GO outcome and quality of life. A possible extension of the study can be foreseen, aimed at investigating the very long time GO outcome.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT06087731 -
Efficacy and Safety of Tocilizumab for TAO
|
Phase 2 | |
| Recruiting |
NCT05110040 -
Multi-model Image of Immunosuppressive Agents in TAO
|
N/A | |
| Recruiting |
NCT06112340 -
A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03107078 -
Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
|
Phase 4 | |
| Recruiting |
NCT04548284 -
Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO
|
Phase 3 | |
| Recruiting |
NCT03515863 -
Natural History and Risk Factors of TAO
|
||
| Not yet recruiting |
NCT06392906 -
Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
|
Phase 3 | |
| Recruiting |
NCT06226545 -
A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
|
Phase 2 | |
| Completed |
NCT00150111 -
Rituximab in the Treatment of Graves' Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT03110848 -
Effects of Atorvastatin in Graves' Orbitopathy (GO)
|
Phase 2 | |
| Recruiting |
NCT04662190 -
Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.
|
N/A | |
| Active, not recruiting |
NCT05276063 -
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT04919694 -
Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy
|
N/A | |
| Recruiting |
NCT03131726 -
Treatment of Graves´Ophthalmopathy With Simvastatin (GO-S)
|
Phase 3 | |
| Completed |
NCT02766660 -
Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy
|
N/A | |
| Active, not recruiting |
NCT06269393 -
A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy
|
Phase 3 | |
| Recruiting |
NCT05112211 -
Multi-model Image of Doxycycline in TAO
|
N/A |