Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy

NCT00004660 | Completed

• 3 other identifiers: 199/11860MAYOC-1889200R01DK042822
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Graves' Disease

Keywords

Graves' disease; thyroid disease; endocrine disorders; rare disease

Outcome Measures

Primary Outcomes (1)

• Orbital Volume

  Orbital fat and muscle volumes

  1 year

Study Arms (2)

Radiotherapy

EXPERIMENTAL

Radiation: Radiotherapy

Sham treatment

SHAM COMPARATOR

Radiation: Sham treatment

Interventions

Radiotherapy RADIATION

Radiotherapy

Sham treatment RADIATION

Sham treatment

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Gorman CA, Garrity JA, Fatourechi V, Bahn RS, Petersen IA, Stafford SL, Earle JD, Forbes GS, Kline RW, Bergstralh EJ, Offord KP, Rademacher DM, Stanley NM, Bartley GB. A prospective, randomized, double-blind, placebo-controlled study of orbital radiotherapy for Graves' ophthalmopathy. Ophthalmology. 2001 Sep;108(9):1523-34. doi: 10.1016/s0161-6420(01)00632-7.

  PMID: 11535445 RESULT

MeSH Terms

Conditions

Graves Disease; Thyroid Diseases; Endocrine System Diseases; Rare Diseases

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Colum A. Gorman

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: June 1, 1993
• Primary Completion: January 1, 1998
• Study Completion: January 1, 1998
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)