A randomized controlled trial on the effect of hydroxychloroquine in mild Graves’ orbitopathy (GO-HCQ): study protocol
Abstract Background Graves’ orbitopathy (GO) is a prevalent manifestation of Graves’ disease (GD), characterized by proptosis, eyelid retraction, soft tissue swelling, diplopia, and potential visual acuity impairment. Furthermore, even mild GO can significantly impact mental health and overall quali...
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BMC
2025-08-01
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| Online Access: | https://doi.org/10.1186/s13063-025-09002-6 |
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| author | Chia-Hung Lin Yi-Hsuan Wei Jin-Ying Lu Hung-Yuan Li Chung-Wei Lee Chung-Yi Yang Chin-Hao Chang Wan-Chen Wu Chih-Yuan Wang Shyang-Rong Shih |
| author_facet | Chia-Hung Lin Yi-Hsuan Wei Jin-Ying Lu Hung-Yuan Li Chung-Wei Lee Chung-Yi Yang Chin-Hao Chang Wan-Chen Wu Chih-Yuan Wang Shyang-Rong Shih |
| author_sort | Chia-Hung Lin |
| collection | DOAJ |
| description | Abstract Background Graves’ orbitopathy (GO) is a prevalent manifestation of Graves’ disease (GD), characterized by proptosis, eyelid retraction, soft tissue swelling, diplopia, and potential visual acuity impairment. Furthermore, even mild GO can significantly impact mental health and overall quality of life for patients with GD. Despite its severity, available medical treatments for mild GO are limited. Recent basic studies on orbital fibroblasts suggest hydroxychloroquine (HCQ) as a promising therapeutic agent for GO patients. This randomized controlled trial (RCT) was designed to assess the efficacy of HCQ in treating mild GO. Methods This multi-center open-label RCT will be conducted in Taiwan with a total of 108 participants randomized into HCQ and control groups at 2:1 allocation ratio. The primary endpoint of this study is a composite outcome of ophthalmic parameters including eyelid aperture, soft tissue involvement, and exophthalmos. Secondary endpoints comprise changes in quality of life (GO-QoL), orbital volumetry via computed tomography (CT), diplopia scores, clinical activity scores (CAS), visual acuity, and thyroid autoantibodies. Discussion This RCT will elucidate the clinical benefits of oral HCQ in patients with mild GO, assessing ophthalmic outcomes, quality of life, disease activity, and thyroid autoantibodies. In addition, data obtained from orbital CT measurements will provide valuable insights into subtle changes in orbital fat and extra-ocular muscle volumes, potentially offering an objective tool for monitoring GO progression. Trial registration {2a, 2b} ClinicalTrials.gov NCT05126147. Registered on November 2021. https://clinicaltrials.gov/study/NCT05126147 . All items from the World Health Organization (WHO) Trial Registration Data Set are addressed within the relevant sections of this protocol. |
| format | Article |
| id | doaj-art-dc13d951f9f644b9a975adf367f21e13 |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-dc13d951f9f644b9a975adf367f21e132025-08-20T03:46:20ZengBMCTrials1745-62152025-08-012611910.1186/s13063-025-09002-6A randomized controlled trial on the effect of hydroxychloroquine in mild Graves’ orbitopathy (GO-HCQ): study protocolChia-Hung Lin0Yi-Hsuan Wei1Jin-Ying Lu2Hung-Yuan Li3Chung-Wei Lee4Chung-Yi Yang5Chin-Hao Chang6Wan-Chen Wu7Chih-Yuan Wang8Shyang-Rong Shih9Division of Endocrinology and Metabolism, Department of Internal Medicine, National Taiwan University HospitalDepartment of Ophthalmology, National Taiwan University HospitalDivision of Endocrinology and Metabolism, Department of Internal Medicine, National Taiwan University HospitalDivision of Endocrinology and Metabolism, Department of Internal Medicine, National Taiwan University HospitalDepartment of Medical Imaging, National Taiwan University HospitalDepartment of Medical Imaging, I-Shou UniversityDepartment of Medical Research, National Taiwan University HospitalDivision of Endocrinology and Metabolism, Department of Internal Medicine, National Taiwan University HospitalDivision of Endocrinology and Metabolism, Department of Internal Medicine, National Taiwan University HospitalDivision of Endocrinology and Metabolism, Department of Internal Medicine, National Taiwan University HospitalAbstract Background Graves’ orbitopathy (GO) is a prevalent manifestation of Graves’ disease (GD), characterized by proptosis, eyelid retraction, soft tissue swelling, diplopia, and potential visual acuity impairment. Furthermore, even mild GO can significantly impact mental health and overall quality of life for patients with GD. Despite its severity, available medical treatments for mild GO are limited. Recent basic studies on orbital fibroblasts suggest hydroxychloroquine (HCQ) as a promising therapeutic agent for GO patients. This randomized controlled trial (RCT) was designed to assess the efficacy of HCQ in treating mild GO. Methods This multi-center open-label RCT will be conducted in Taiwan with a total of 108 participants randomized into HCQ and control groups at 2:1 allocation ratio. The primary endpoint of this study is a composite outcome of ophthalmic parameters including eyelid aperture, soft tissue involvement, and exophthalmos. Secondary endpoints comprise changes in quality of life (GO-QoL), orbital volumetry via computed tomography (CT), diplopia scores, clinical activity scores (CAS), visual acuity, and thyroid autoantibodies. Discussion This RCT will elucidate the clinical benefits of oral HCQ in patients with mild GO, assessing ophthalmic outcomes, quality of life, disease activity, and thyroid autoantibodies. In addition, data obtained from orbital CT measurements will provide valuable insights into subtle changes in orbital fat and extra-ocular muscle volumes, potentially offering an objective tool for monitoring GO progression. Trial registration {2a, 2b} ClinicalTrials.gov NCT05126147. Registered on November 2021. https://clinicaltrials.gov/study/NCT05126147 . All items from the World Health Organization (WHO) Trial Registration Data Set are addressed within the relevant sections of this protocol.https://doi.org/10.1186/s13063-025-09002-6Graves’ orbitopathyThyroid eye diseaseGraves’ diseaseHydroxychloroquine |
| spellingShingle | Chia-Hung Lin Yi-Hsuan Wei Jin-Ying Lu Hung-Yuan Li Chung-Wei Lee Chung-Yi Yang Chin-Hao Chang Wan-Chen Wu Chih-Yuan Wang Shyang-Rong Shih A randomized controlled trial on the effect of hydroxychloroquine in mild Graves’ orbitopathy (GO-HCQ): study protocol Trials Graves’ orbitopathy Thyroid eye disease Graves’ disease Hydroxychloroquine |
| title | A randomized controlled trial on the effect of hydroxychloroquine in mild Graves’ orbitopathy (GO-HCQ): study protocol |
| title_full | A randomized controlled trial on the effect of hydroxychloroquine in mild Graves’ orbitopathy (GO-HCQ): study protocol |
| title_fullStr | A randomized controlled trial on the effect of hydroxychloroquine in mild Graves’ orbitopathy (GO-HCQ): study protocol |
| title_full_unstemmed | A randomized controlled trial on the effect of hydroxychloroquine in mild Graves’ orbitopathy (GO-HCQ): study protocol |
| title_short | A randomized controlled trial on the effect of hydroxychloroquine in mild Graves’ orbitopathy (GO-HCQ): study protocol |
| title_sort | randomized controlled trial on the effect of hydroxychloroquine in mild graves orbitopathy go hcq study protocol |
| topic | Graves’ orbitopathy Thyroid eye disease Graves’ disease Hydroxychloroquine |
| url | https://doi.org/10.1186/s13063-025-09002-6 |
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