Thyroid Associated Opthalmopathies Clinical Trial
Official title:
The Effect of Prednisone Versus Doxycycline in Active, Moderately Severe Graves' Orbitopathy: A Randomized, Multi-center, Double-blind, Parallel-controlled Trial
The aim of this study is to compare the efficacy and safety of prednisone versus sub-antimicrobial dose doxycycline (50 mg/d) in the treatment of active moderate-severe Graves' Orbitopathy (GO).
Graves' orbitopathy is an autoimmune disease characterized 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, having a successful outcome of 50-70% in
patients. However, long time usage of corticosteroids often cause severe side-effects.
Sub-antimicrobial 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
sub-antimicrobial dose doxycycline for treating inflammatory or autoimmune diseases, such as
rosacea, periodontitis and multiple sclerosis. The mechanism is by inhibiting lymphocyte
proliferation and production of colony-stimulating factor, inflammatory cytokines, and
immunoglobulins, factors thought to play a role in the orbital autoimmune process. These
mechanisms make them, in theory, an attractive option of doxycycline for treating Graves'
Orbitopathy. In addition, only few adverse events were reported when doxycycline were
administered for 3 months in patients with periodontitis or rosacea.
We propose to compare the effect and safety of sub-antimicrobial dose doxycycline versus
prednisone for treating non-sight threatening, moderate-severe, inflammatory GO.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment