Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004660
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2000-02-24
Brief Title:
Randomized Study of Sequential Orbital Radiotherapy for Graves Ophthalmopathy
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Phase II Randomized Controlled Study of Sequential Orbital Radiotherapy for Graves Ophthalmopathy
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Evaluate the effects of 20 Gy of external-beam radiotherapy to 1 orbit vs the untreated orbit at 3 and 6 months after therapy in patients with Graves ophthalmopathy
II Evaluate whether 20 Gy of external-beam radiotherapy delivered to the second orbit 6 months later in the course of the disease produces effects of equal magnitude to those observed when the first orbit was treated
III Relate the magnitude of treatment effects to the time since onset of eye symptoms
IV Evaluate whether characteristics of radiation retinopathy are present 3 years after orbital radiotherapy
II Evaluate whether 20 Gy of external-beam radiotherapy delivered to the second orbit 6 months later in the course of the disease produces effects of equal magnitude to those observed when the first orbit was treated
III Relate the magnitude of treatment effects to the time since onset of eye symptoms
IV Evaluate whether characteristics of radiation retinopathy are present 3 years after orbital radiotherapy
Detailed Description:
PROTOCOL OUTLINE The posterior region of 1 orbit is irradiated over 2 weeks with supervoltage equipment The other orbit is treated 6 months later The sequence of therapy is randomly assigned
The untreated eye receives a simultaneous sham treatment during each radiotherapy session
Patients are followed at 3 6 9 12 and 36 months
The untreated eye receives a simultaneous sham treatment during each radiotherapy session
Patients are followed at 3 6 9 12 and 36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK042822 | NIH | Mayo Clinic | httpsreporternihgovquickSearchR01DK042822 |
| MAYOC-1889200 | OTHER | None | None |