Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Angiopeptin; Lanreotide

Criteria

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