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Recruiting NCT05126147

Hydroxychloroquine in Mild Graves' Orbitopathy

Phase IV Interventional Graves Ophthalmopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydroxychloroquine.
Who it may be relevant to
Registry conditions: Graves Ophthalmopathy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial on the Effect of Hydroxychloroquine in Mild Graves' Orbitopathy

Overview

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

Detailed 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.

Interventions

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

Primary outcome measures

  • The change of ophthalmic outcome [Time frame: at 24 weeks and 48 weeks]
Secondary outcome measures (12)
  • The change of quality of life (GO-QoL) [Time frame: at 24 weeks and 48 weeks]
  • The change of muscle volume (cm^3) on computed tomography [Time frame: at 24 weeks and 48 weeks]
  • The change of fat volume (cm^3) on computed tomography [Time frame: at 24 weeks and 48 weeks]
  • The change of orbital volume (cm^3) on computed tomography [Time frame: at 24 weeks and 48 weeks]
  • The change of muscle density on computed tomography [Time frame: at 24 weeks and 48 weeks]
  • The change of fat density on computed tomography [Time frame: at 24 weeks and 48 weeks]
  • The change of diplopia score [Time frame: at 24 weeks and 48 weeks]
  • The change of clinical activity score (CAS) [Time frame: at 24 weeks and 48 weeks]
  • The change of visual acuity [Time frame: at 24 weeks and 48 weeks]
  • The change of antithyroid peroxidase antibody (anti-TPO) (IU/mL) [Time frame: at 24 weeks and 48 weeks]
  • The change of thyroglobulin antibody (TA) (IU/mL) [Time frame: at 24 weeks and 48 weeks]
  • The change of thyrotropin-binding inhibiting immunoglobulin (TBII) (%). [Time frame: at 24 weeks and 48 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • National Taiwan University Hospital, Hsin-Chu branch — Hsinchu
  • National Taiwan University Hospital — Taipei

Publications

  • 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. PMID 40760017

Identifiers

NCT: NCT05126147 · 202101055MINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗