Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

A Phase II, Single Centre, Randomized, Double-blind, Parallel and Placebo Controlled, Pilot Study to Evaluate the Efficacy and Safety of Somatuline Autogel 60mg in Patients With Active Thyroid-associated Ophthalmopathy of Moderate Intensity.

The main purpose of this study is to evaluate the efficacy and safety of 3 doses of Somatuline Autogel 60mg to control the muscle infiltration and edema, eyelid retraction and extraocular muscular contraction in patients with active thyroid-associated ophthalmopathy of moderate intensity.

Inclusion Criteria:

• Patients with autoimmune thyroid disease and whose centre's medical records confirm the presence of euthyroidism for at least two months before being included into the study
• Thyroid-associated ophthalmopathy diagnosed a minimum of six months before his/her participation in the study, well documented in the centre's medical records and based on the moderate intensity of thyroid-associated ophthalmopathy in the worst eye
• Patients whose ophthalmopathy activity has been demonstrated by a positive octreoscan

Exclusion Criteria:

• The patient presents compressive optical neuropathy signs which require immediate surgical treatment or suffers from serious intensity thyroid ophthalmopathy
• The patient has been treated with radio-iodine for his/her thyroid disturbance in the past 6 months
• The patient's thyroid-associated ophthalmopathy has been treated previously (except for drops and local measures) or is planned to be treated with radio-iodine or thyroidectomy for his/her autoimmune thyroid disease during the study or suffers from myopia, glaucoma or any other eye disease which could modify the ophthalmological progress
• The patient is a smoker of more than 5 cigarettes per day