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Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy

Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graves Ophthalmopathy; Graves Disease; Eye Diseases; Thyroid Diseases; Endocrine System Diseases; Eye Diseases, Hereditary; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention: Doxycycline (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
Dan Liang, MD, Principal Investigator, Affiliation: Zhongsh Ophthalmic Center


The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 wk, for patients with active moderate-severe Graves' Orbitopathy (GO).

Clinical Details

Official title: Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy: a Prospective, Uncontrolled Pilot Study

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: • Treatment response

Secondary outcome:

Safety and tolerability as assessed by adverse events, vital signs

Graves' orbitopathy-Specific Quality of Life (GO-QoL)

Detailed description: Graves'orbitopathy is an autoimmune disease characterised by an inflammatory phase followed by fibrosis. Surgery to correct eyelid swelling, proptosis, and diplopia is effective, but can not be done until the inflammatory phase has passed. To arrest the inflammatory phase, several types of immunosuppressive treatments have been investigated. Corticosteroids are the first-choice immunosuppressive treatment, but they often cause severe side-effects. Subantimicrobial dose doxycycline posses known anti-inflammatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of subantimicrobial dose doxycycline for rosacea, periodontitis and multiple sclerosis. We propose to test the effect of subantimicrobial dose doxycycline for non-sight threatening, moderate-severe, inflammatory GO.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- Clinical diagnosis of Graves' Orbitopathy

- Moderate-severe GO According to EUGOGO statements, patients with moderate-severe GO

usually have any one or more of the following:moderate or severe soft tissue involvement, exophthalmos≥3mm above normal for race and gender, inconstant, or constant diplopia.

- Clinical activity score ≥ 3

- Being euthyroid for at least 1 month before the date of inclusion

- Must be able to swallow tablets

- Written informed consent is obtained

Exclusion Criteria:

- Mild Graves' Orbitopathy

- Sight-threatening Graves' Orbitopathy

- Clinical activity score < 3

- Previous treatment for GO Oral steroids, intravenous steroids, radiotherapy

- Pregnant females as determined by positive (serum or urine) Human chorionic

gonadotropin (hCG) test at screening or prior to dosing, or lactating females

- Uncontrolled diabetes or hypertension

- History of mental / psychiatric disorder

- Hepatic dysfunction (Albumin (Alb),Aspartate Transaminase (AST), Alanine

Aminotransferase (ALT) and Alkaline phosphates levels must be within normal range for eligibility)

- Renal impairment (Urea and Creatinine levels must be within normal range)

- Doxycycline allergy or intolerance

Locations and Contacts

Zhongshan Ophthalmic Center, Guangzhou, Guangdong 510060, China
Additional Information

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

MedlinePlus related topics: Antibiotics Eye Diseases Thyroid Diseases

Drug Information available for: Doxycycline Dolotard Tibirox Biomycin

U.S. FDA Resources

Starting date: October 2012
Last updated: December 7, 2013

Page last updated: August 23, 2015

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