NCT05126147

Hydroxychloroquine in Mild Graves' Orbitopathy

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).

Detailed description

Graves' orbitopathy (GO) is one of the common manifestations of Graves' disease (GD), which results in proptosis, eyelid retraction, soft tissue swelling, diplopia or even visual acuity impairment. In addition, mental health and quality of life are often affected. In current guidelines, limited treatment options are suggested for patients with mild GO. Recently, cell study revealed that there are multiple effects of hydroxychloroquine (HCQ) on orbital fibroblasts in patients with mild GO, including suppression of cell proliferation, adipogenesis and production of hyaluronic acid, which poses a great potential in the treatment of mild GO clinically. This randomized controlled trial is aimed to investigate the effects of HCQ in patients with mild GO on the effects of ophthalmic outcomes, quality of life, orbital volumetry on orbital computed tomography, serum inflammatory and fibrosis markers.

Conditions

• Graves Ophthalmopathy

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Compare the effects of hydroxychloroquine 200mg twice daily for 6 months with those without treatment.

Timeline

• Start date: 2022-03-21
• Primary completion: 2025-09-30
• Completion: 2026-12-31
• First posted: 2021-11-18
• Last updated: 2025-02-25

Locations

2 sites across 1 country: Taiwan