Hydroxychloroquine in Mild Graves' Orbitopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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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

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Graves Ophthalmopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydroxychloroquine

Hydroxychloroquine 200mg twice daily for 6 months.

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

Compare the effects of hydroxychloroquine 200mg twice daily for 6 months with those without treatment.

Control

Observation and active surveillance.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydroxychloroquine

Compare the effects of hydroxychloroquine 200mg twice daily for 6 months with those without treatment.

Intervention Type DRUG

Other Intervention Names

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Plaquenil

Eligibility Criteria

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Inclusion Criteria

* Mild GO according European Group on Graves' orbitopathy (EUGOGO) guidelines diagnosed by endocrinologist and ophthalmologist.
* No previous treatment of GO except for eyedrops
* Euthyroidism (normalized free T4 and TSH) for at least 2 months. If radioactive iodine is used for hyperthyroidism, euthyroidism needs to be achieved for at least 6 months.

Exclusion Criteria

* Moderate-to-sever or sight-threatening GO according to EUGOGO guidelines diagnosed by endocrinologist and ophthalmologist.
* Pregnancy
* Drug or alcohol abuse
* Unable to comply with the study protocol
* Unable to obtain informed consent
* Use of hydroxychloroquine or systemic steroid within 3 months prior to enrollment
* History of side effects of hydroxychloroquine
* History of retinopathy
* Renal dysfunction (estimated glomerular filtration rate (eGFR) \< 60ml/min)
* Hepatic dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 x upper limit)
* Anemia (hemoglobin (Hb) \< 10g/dl)
* Neutropenia (absolute neutrophil count \< 100/uL)
* Thrombocytopenia (platelet (PLT) \< 150000/uL)
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Porphyria cutaneous tarda
* Allergy to 4-aminoquinoline

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No