Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Thyroid Diseases; Graves Ophthalmopathy; Eye Diseases, Hereditary; Thyroid-associated Ophthalmopathy; Hyperthyroidism; Immune System Diseases; Graves Disease; Endocrine System Diseases; Autoimmune Diseases

Treatments: Drug: Placebo; Drug: Doxycycline hyclate

Study type: Interventional

Funder types: Other

Identifiers

NCT02203682

2013MEKY033

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Doxycycline

Experimental group

Description:

Tablets Doxycycline 50 mg PO per day for 12 weeks

Treatment:

Drug: Doxycycline hyclate

Placebo

Placebo Comparator group

Description:

Tablet placebo for 12 weeks

Treatment:

Drug: Placebo