Hydroxychloroquine in Mild Graves' Orbitopathy

Phase 4RecruitingNCT05126147

National Taiwan University Hospital108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Graves Ophthalmopathy

Interventions

HydroxychloroquineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

National Taiwan University Hospital, Hsin-Chu branch

Hsinchu, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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".