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Doxycycline Treatment in Mild 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); placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sun Yat-sen University

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

Overall contact:
Dan Liang, MD, Phone: 0086-20-87331766, Email: linml0754@gmail.com


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).

Clinical Details

Official title: The Effect of Subantimicrobial Dose Doxycycline in Mild Graves' Orbitopathy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Treatment response

Secondary outcome:

Ocular surface disease index (OSDI)

Safety and tolerability as assessed by adverse events, vital signs

Health related quality of life questionnaires (GO-QoL)

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.


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


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

Locations and Contacts

Dan Liang, MD, Phone: 0086-20-87331766, Email: linml0754@gmail.com

Zhongshan Ophthalmic Center, Guangzhou, Guangdong 510060, China; Recruiting
Dan Liang, MD, Phone: 0086-20-87331766, Email: liangd2@mail.sysu.edu.cn
Additional Information

Starting date: July 2014
Last updated: July 28, 2014

Page last updated: August 23, 2015

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