Doxycycline Treatment in Mild Graves' Orbitopathy

• ClinicalTrials.gov Identifier: NCT02203682
• Recruitment Status: Unknown
• First Posted: July 30, 2014
• Last Update Posted: July 30, 2014
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Dan Liang, Sun Yat-sen University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Dan Liang, MD; 0086-20-87331766; linml0754@gmail.com

Locations

China, Guangdong

Zhongshan Ophthalmic Center; Recruiting

Guangzhou, Guangdong, China, 510060

Contact: Dan Liang, MD 0086-20-87331766 liangd2@mail.sysu.edu.cn

Sponsors and Collaborators

Sun Yat-sen University

Investigators

• Principal Investigator: Dan Liang, MD; Zhongsh Ophthalmic Center

More Information

• Responsible Party: Dan Liang, MD, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT02203682
• Other Study ID Numbers: 2013MEKY033
• First Posted: July 30, 2014
• 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; Doxycycline; EUGOGO; CAS

Additional relevant MeSH terms:

Eye Diseases; Graves Disease; Graves Ophthalmopathy; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Exophthalmos; Orbital Diseases; Goiter; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents