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
Summary
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 signsGraves' 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
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