Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy

Graves' Disease Clinical Trial

Official title:

Phase II Randomized Controlled Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004660
• Other study ID #: 199/11860
• Secondary ID: MAYOC-1889200R01
• Status: Completed
• Phase: N/A
• First received: February 24, 2000
• Last updated: May 25, 2017
• Start date: June 1993
• Est. completion date: January 1998

Study information

• Verified date: May 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 1998
• Est. primary completion date: January 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Disease
• Graves Ophthalmopathy
• Graves' Disease

Intervention

Radiation:
• Radiotherapy

• Sham treatment

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Mayo Clinic

Country where clinical trial is conducted

United States, 

References & 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 radiothera — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orbital Volume	Orbital fat and muscle volumes	1 year