Doxycycline Treatment in Graves' Orbitopathy
The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered three months, for patients with active moderate-severe Graves' Orbitopathy (GO).
Endocrine System Diseases
Eye Diseases, Hereditary
Immune System Diseases
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Subantimicrobial Dose Doxycycline in Graves' Orbitopathy|
- • European Group on Graves' Orbitopathy (EUGOGO) Clinical Activity Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]Clinical Activity Score is a validated index of Graves' orbitopathy that assigns one point to the presence of: 1.spontaneous retrobulbar pain, 2. pain on up/downgaze, 3. redness of eyelids, 4. redness of conjunctiva, 5. swelling of eyelids, 6. inflammation of caruncle/plica, 7. chemosis. The maximal clinical activity score (CAS) is thus 7.
- • Health related quality of life questionnaires (GO-QoL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- • Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]
- Relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Tablets Doxycycline 50 mg PO per day for three months
Tab. Doxycycline 50 mg PO per day for 3 months
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.
|Contact: Dan Liang, MDfirstname.lastname@example.org|
|Zhongshan Ophthalmic Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Dan Liang, MD 0086-20-87331766 email@example.com|
|Principal Investigator: Dan Liang, MD|
|Principal Investigator:||Dan Liang, MD||Zhongsh Ophthalmic Center|