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Doxycycline Treatment in Mild Graves' Orbitopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02203682
Recruitment Status : Unknown
Verified July 2014 by Dan Liang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
Information provided by (Responsible Party):
Dan Liang, Sun Yat-sen University

Brief Summary:
The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 weeks, on patients with mild Graves' Orbitopathy (GO).

Condition or disease Intervention/treatment Phase
Graves Ophthalmopathy Graves Disease Eye Diseases Thyroid Diseases Endocrine System Diseases Eye Diseases, Hereditary Hyperthyroidism Autoimmune Diseases Immune System Diseases Drug: Doxycycline Drug: placebo Phase 2

Detailed Description:

Graves'orbitopathy is an autoimmune disease that can be treated by corticosteroids and surgery. But they often cause severe side-effects and are usually used for treating moderate-sever and sight-threatening GO. Wait and see will be the first choice for the patient with mild GO.

Subantimicrobial dose (SD) doxycycline displays a strong anti-inflammatory and immunomodulatory function, which is independent of its antibiotic properties. Data from clinical trials demonstrated that SD doxycycline was effective in moderating inflammation in a variety of autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, rosacea and periodontitis.

We propose to test the effect of subantimicrobial dose doxycycline for mild GO.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Subantimicrobial Dose Doxycycline in Mild Graves' Orbitopathy
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Doxycycline
Tablets Doxycycline 50 mg PO per day for 12 weeks
Drug: Doxycycline
Tab. Doxycycline 50 mg PO per day for 12 weeks
Other Names:
  • Dolotard
  • Tibirox
  • Biomycin

Placebo Comparator: Placebo
Tablet placebo for 12 weeks
Drug: placebo
Tablet placebo for 12 weeks

Primary Outcome Measures :
  1. Treatment response [ Time Frame: 12 weeks ]
    As definition of treatment response, we used four criteria: reduction of 2 mm or more in proptosis; improvement of ≥8 degrees in any direction of eye movements; reduction of 2 mm or more in eyelid aperture; improvement in grade of soft tissue swelling. A successful response was defined as an improvement in one or more criteria, in absence of deterioration of any criterion in that observed eye. Deterioration was defined as occurrence of DON, and/or worsening of soft tissue swelling. No success was defined if there was no change or the changes did not reach the success criteria.

Secondary Outcome Measures :
  1. Ocular surface disease index (OSDI) [ Time Frame: 12 weeks ]
  2. Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 12 weeks ]
  3. Health related quality of life questionnaires (GO-QoL) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Graves' Orbitopathy
  • Mild GO According to EUGOGO statemnt, patients with mild GO usually have any one or more of the following:mild soft tissue involvement, exophthalmos<18mm, temporary, or no diplopia.
  • Clinical activity score lower than 3
  • Being euthyroid for at least 1 month before the date of inclusion
  • No previous specific therapy for GO, except for local measures in 1 month before the date of inclusion
  • Written informed consent is obtained

Exclusion Criteria:

  • moderate-sever Graves' Orbitopathy
  • Sight-threatening Graves' Orbitopathy
  • Clinical activity score ≥ 3
  • Pregnant females as determined by positive (serum or urine) hCG test at screening or prior to dosing, or lactating females
  • Uncontrolled diabetes or hypertension
  • History of mental / psychiatric disorder
  • Hepatic dysfunction (Alb, AST, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02203682

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Contact: Dan Liang, MD 0086-20-87331766

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China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Dan Liang, MD    0086-20-87331766   
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Dan Liang, MD Zhongsh Ophthalmic Center
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Responsible Party: Dan Liang, MD, Sun Yat-sen University Identifier: NCT02203682    
Other Study ID Numbers: 2013MEKY033
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Keywords provided by Dan Liang, Sun Yat-sen University:
Graves' orbitopathy
Graves´ ophthalmopathy
Thyroid eye disease
Thyroid-associated ophthalmopathy
Additional relevant MeSH terms:
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Eye Diseases
Graves Disease
Graves Ophthalmopathy
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Orbital Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents