NCT00004660

Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Graves' Disease

Interventions

Type	Name	Description
RADIATION	Radiotherapy
RADIATION	Sham treatment

Timeline

• Start date: 1993-06-01
• Primary completion: 1998-01-01
• Completion: 1998-01-01
• First posted: 2000-02-25
• Last updated: 2017-05-30

Locations

1 site across 1 country: United States