Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

Ipsen

Status and phase

Terminated

Phase 2

Conditions

Thyroid-Associated Ophthalmopathy

Treatments

Drug: Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days

Study type

Interventional

Funder types

Industry

Identifiers

NCT00288522

A-92-52030-164

2004-003937-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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