Hydroxychloroquine in Mild Graves' Orbitopathy

National Taiwan University

Status and phase

Enrolling

Phase 4

Conditions

Graves Ophthalmopathy

Treatments

Drug: Hydroxychloroquine

Study type

Interventional

Funder types

Other

Identifiers

NCT05126147

202101055MINB

Details and patient eligibility

About

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

Full 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.

Enrollment

108 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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