Lanreotide (Somatuline Autogel) in Thyroid-Associated Ophthalmopathy Treatment - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00288522

Purpose

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.

Condition	Intervention	Phase
Thyroid-Associated Ophthalmopathy	Drug: Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days	Phase II

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

MedlinePlus related topics: Edema

Drug Information available for: Thyroid Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Ipsen:

Primary Outcome Measures:

Extraocular muscle infiltration and edema exam by evaluating (at Day 0 and Weeks 4, 8 and 12): extraocular muscle size, proptosis and intraocular pressure (tonometry)
Eye inspection (at Day 0 and Weeks 4, 8 and 12): assessment of conjunctival injection presence, chemosis, cheratitis and eyelid edema; extrinsic muscle function evaluation and eyelid retraction

Estimated Enrollment:	20
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288522

Locations

Spain
Hospital General d'Alacant
Alicante, Spain, 03012

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Eva Pineda, MD

Ipsen

More Information

Study ID Numbers:	A-92-52030-164
Study First Received:	February 7, 2006
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00288522
Health Authority:	Spain: Drug and Sanitary Products Spanish Agency

Study placed in the following topic categories:

Goiter
Autoimmune Diseases
Graves Ophthalmopathy
Eye Diseases
Graves Disease
Angiopeptin
Endocrine System Diseases

Graves' disease
Lanreotide
Eye Diseases, Hereditary
Orbital Diseases
Endocrinopathy
Thyroid Diseases
Hyperthyroidism

Additional relevant MeSH terms:

Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Cardiovascular Agents
Pharmacologic Actions
Exophthalmos

ClinicalTrials.gov processed this record on January 16, 2009