Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)

What this Trial Is About

Thyroid ophthalmopathy, also known as thyroid eye disease or Graves' ophthalmopathy, causes inflammation and swelling of the tissues around the eyes, leading to discomfort, vision problems, and in severe cases, permanent vision loss. This study evaluates a shorter radiation treatment schedule compared to the standard approach to see if it can effectively manage the condition and improve patients' quality of life. Participants have moderate to severe active thyroid eye disease and may not respond well to standard steroid treatments. The study compares two treatment groups: one receiving a standard course of 10 daily external beam radiation therapy (ERT) sessions, and the other receiving a shortened course of 5 daily ERT sessions. Radiation therapy targets the affected eye tissues to reduce inflammation. Both groups receive daily treatments, and the study aims to determine if the shorter regimen is as effective and safe as the standard one. Participants will be monitored through comprehensive eye exams, imaging studies, and questionnaires about their vision and quality of life before and after treatment. Researchers will track changes in clinical activity scores, eye muscle and fat volume, double vision, vision clarity, visual fields, radiation side effects, and overall quality of life over six months. The study offers detailed assessments to understand how each treatment impacts disease progression and patient well-being.

Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)