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Phase II Randomized Controlled Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy
This study is ongoing, but not recruiting participants.
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004660
  Purpose

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.


Condition Intervention Phase
Graves' Disease
Procedure: Radiotherapy
Phase II

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome
MedlinePlus related topics: Radiation Therapy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 42
Study Start Date: June 1993
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004660

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Colum A. Gorman Mayo Clinic
  More Information

No publications provided

Study ID Numbers: 199/11860, MAYOC-1889200
Study First Received: February 24, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004660     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
Graves' disease
thyroid disease
endocrine disorders
rare disease

Study placed in the following topic categories:
Goiter
Autoimmune Diseases
Graves Ophthalmopathy
Eye Diseases
Graves Disease
Rare Diseases
Endocrine System Diseases
Graves' Disease
Eye Diseases, Hereditary
Orbital Diseases
Endocrinopathy
Thyroid Diseases
Hyperthyroidism

Additional relevant MeSH terms:
Goiter
Autoimmune Diseases
Immune System Diseases
Graves Ophthalmopathy
Eye Diseases
Graves Disease
Eye Diseases, Hereditary
Endocrine System Diseases
Orbital Diseases
Hyperthyroidism
Thyroid Diseases
Exophthalmos

ClinicalTrials.gov processed this record on May 07, 2009