A Randomized Controlled Trial on the Effect of Hydroxychloroquine in Mild Graves' Orbitopathy

What this Trial Is About

Graves' orbitopathy (GO) is a common complication of Graves' disease that affects the eyes, causing symptoms like bulging eyes, eyelid retraction, swelling, double vision, and sometimes vision problems. It can also impact mental health and quality of life. Current treatments for mild GO are limited, so this study is investigating how hydroxychloroquine, a medication shown in lab studies to affect cells involved in mild GO, might help patients with this condition. Participants in this randomized trial will either receive hydroxychloroquine at a dose of 200 mg twice daily for 6 months or be placed under observation without active treatment. The study aims to compare the effects of hydroxychloroquine versus no treatment on eye-related outcomes, quality of life, and changes in eye muscle and fat volumes using CT scans. Blood tests will also measure inflammation and fibrosis markers. During the study, participants will be monitored at 24 and 48 weeks to assess changes in their eye condition, quality of life, muscle and fat volumes in the orbit, double vision scores, clinical activity scores, visual acuity, and antibody levels related to thyroid disease. The study includes regular eye exams, imaging, and laboratory tests to track these outcomes and evaluate safety over time. Total participation spans at least 48 weeks with assessments at specified intervals.

Hydroxychloroquine in Mild Graves' Orbitopathy