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This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine 200mg twice daily for 6 months. |
|
| Control | No Intervention | Observation and active surveillance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Compare the effects of hydroxychloroquine 200mg twice daily for 6 months with those without treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of ophthalmic outcome | The ophthalmic outcome is a composite outcome which includes three components: eyelid aperture, soft tissue involvement and exophthalmos. The outcome is defined as "improvement" if any of the three components improves without deterioration of any other components. The outcome of "deterioration" is defined if upgrading of soft tissue involvement or evidence of worsening sight or optic nerve compression. The outcome of "stable" is defined if the ophthalmic outcome does not fit the definition of "improvement" or "deterioration". | at 24 weeks and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of quality of life (GO-QoL) | The outcome is grading as improvement, stable and deterioration. Improvement is defined if there are more than 6 points increase in any of the category in GO-QoL. Deterioration is defined if there are more than 6 points decrease in any of the category in GO-QoL. Stable is defined if none of above criteria is achieved. | at 24 weeks and 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shyang-Rong Shih | Contact | +886-2-23123456 | srshih@ntu.edu.tw | |
| Hung-Yuan Li | Contact | +886-2-23123456 | larsli@ntuh.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital, Hsin-Chu branch | Recruiting | Hsinchu | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40760017 | Derived | Lin CH, Wei YH, Lu JY, Li HY, Lee CW, Yang CY, Chang CH, Wu WC, Wang CY, Shih SR. A randomized controlled trial on the effect of hydroxychloroquine in mild Graves' orbitopathy (GO-HCQ): study protocol. Trials. 2025 Aug 4;26(1):272. doi: 10.1186/s13063-025-09002-6. |
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Individual participant data (IPD) sharing is available upon request.
Data will become available after completed study enrollment.
Individual participant data (IPD) sharing is available upon request.
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| D006111 | Graves Disease |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| The change of muscle volume (cm^3) on computed tomography | Change of muscle volume on noncontrast orbital CT | at 24 weeks and 48 weeks |
| The change of fat volume (cm^3) on computed tomography | Change of fat volume on noncontrast orbital CT | at 24 weeks and 48 weeks |
| The change of orbital volume (cm^3) on computed tomography | Change of orbital volume on noncontrast orbital CT | at 24 weeks and 48 weeks |
| The change of muscle density on computed tomography | The density of muscle is measured and recorded in Hounsfield units. | at 24 weeks and 48 weeks |
| The change of fat density on computed tomography | The density of fat is measured and recorded in Hounsfield units. | at 24 weeks and 48 weeks |
| The change of diplopia score | The Gorman diplopia score includes four categories: no diplopia(absent), diplopia when the patient is tired or awakening (intermittent), diplopia at extremes of gaze (inconstant), and continuous diplopia in the primary or reading position (constant). | at 24 weeks and 48 weeks |
| The change of clinical activity score (CAS) | Clinical activity score (CAS) is a 7-point scale using to evaluate the activity of GO in each eye. It includes 7 items to be scored respectively in each eye with minimum 0 point and maximum 7 points. More points indicate that GO in the eye is more active. The 7 items are listed as below:
| at 24 weeks and 48 weeks |
| The change of visual acuity | Evaluation of visual acuity will be done by the same ophthalmologist | at 24 weeks and 48 weeks |
| The change of antithyroid peroxidase antibody (anti-TPO) (IU/mL) | Change of thyroid autoantibodies | at 24 weeks and 48 weeks |
| The change of thyroglobulin antibody (TA) (IU/mL) | Change of thyroid autoantibodies | at 24 weeks and 48 weeks |
| The change of thyrotropin-binding inhibiting immunoglobulin (TBII) (%). | Change of thyroid autoantibodies | at 24 weeks and 48 weeks |
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
|
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |