- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004660
Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy
Phase II Randomized Controlled Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Firm diagnosis of Graves' disease with normal thyroid function, i.e.: Thyroid-stimulating immunoglobulin positive Thyroxine 5-12.5 micrograms/dL Tri-iodothyronine 80-180 nanograms/dL Thyroid-stimulating hormone 0.2-8 milli-International unit (mIU/L) Euthyroid due to therapy acceptable Ophthalmopathy meeting at least 3 of the following criteria: Chemosis or lid edema Lid lag, lid retraction, or restrictive lagophthalmos Proptosis at least 20 mm by Krahn exophthalmometry in at least 1 eye Less than 4 mm discrepancy between eyes Patient perception of "stare" or "bulge" Extraocular muscle motion restriction in 1 or both eyes on clinical exam or by patient report of diplopia at extremes of gaze Extraocular muscle enlargement on computerized tomography (previous study results acceptable) Mild to moderate ophthalmopathy, i.e.: Orbital pain Lacrimation Photophobia Visual blurring or diplopia No optic neuropathy, i.e.: Afferent pupillary defect Impaired color vision on D-15 testing (unless congenital color perception deficiency) Visual field defect Impaired visual acuity No corneal ulcers --Prior/Concurrent Therapy-- No prior external-beam radiotherapy to the head and neck At least 2 weeks since corticosteroids --Patient Characteristics-- No prior head and neck tumors No diabetes No pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiotherapy
|
|
Sham Comparator: Sham treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Orbital Volume
Time Frame: 1 year
|
Orbital fat and muscle volumes
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Colum A. Gorman, Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/11860
- MAYOC-1889200 (Other Identifier: Mayo Clinic)
- R01DK042822 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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