Clinical trial NCT02203682: Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy
Official title: The Effect of Subantimicrobial Dose Doxycycline in Mild Thyroid-Associated Ophthalmopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Graves Ophthalmopathy
Graves Disease
Thyroid-associated Ophthalmopathy
Thyroid Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Keywords: Graves' orbitopathy
Graves´ ophthalmopathy
Thyroid eye disease
Thyroid-associated ophthalmopathy
Doxycycline
EUGOGO
CAS
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Thyroid-Associated Ophthalmopathy (TAO).

Detailed description: Thyroid-Associated Ophthalmopathy 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 TAO. Wait and see will be the first choice for the patient with mild TAO.

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 TAO.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Thyroid-associated ophthalmopathy
* Mild TAO
* Normal serum free thyroxine and free triiodothyronine concentrations
* No previous specific therapy for TAO, except for local measures
* Written informed consent is obtained

Exclusion Criteria:

* 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)
* Tetracycline allergy or intolerance

Primary outcomes:
measure: the rate of improvement
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical Activity Score (CAS)
timeFrame: 4weeks and 12 weeks
measure: Proptosis measured by Hertel instrument
timeFrame: 4weeks and 12 weeks
measure: Eyelid aperture
timeFrame: 4weeks and 12 weeks
measure: Lid retraction
timeFrame: 4weeks and 12 weeks
measure: Lid lag
timeFrame: 4weeks and 12 weeks
measure: Eye motility
timeFrame: 4weeks and 12 weeks
measure: Graves' Ophthalmopathy Quality of Life Scale
timeFrame: 4weeks and 12 weeks
measure: C-OSDI
timeFrame: 4weeks and 12 weeks
measure: the category of adverse events and the frequency of the occurrence of adverse events
timeFrame: 4weeks and 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongsh Ophthalmic Center
name: Dan Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan Y, Chen YX, Zhang J, Lin ML, Liu GM, Xu XL, Fan XQ, Zhong Y, Li Q, Ai SM, Xu W, Tan J, Zhou HF, Xu DD, Zhang HY, Xu B, Wang S, Ma JJ, Zhang S, Gan LY, Cui JT, Li L, Xie YY, Guo X, Pan-Doh N, Zhu ZT, Lu Y, Shi YX, Xia YW, Li ZY, Liang D. Doxycycline vs Placebo at 12 Weeks in Patients With Mild Thyroid-Associated Ophthalmopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 Nov 1;140(11):1076-1083. doi: 10.1001/jamaophthalmol.2022.3779.