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Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy

NCT00004660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-05-30

No results posted yet for this study

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

Interventions

RADIATION

Radiotherapy

RADIATION

Sham treatment

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Colum A. Gorman · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-06-30
Primary Completion
1998-01-31
Completion
1998-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004660 on ClinicalTrials.gov