Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00288522
Recruitment Status : Terminated
First Posted : February 8, 2006
Last Update Posted : October 1, 2015
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Brief 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.

Condition or disease Intervention/treatment Phase
Thyroid-Associated Ophthalmopathy Drug: Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : January 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

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U.S. FDA Resources

Primary Outcome Measures :
  1. 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)
  2. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00288522

Hospital General d'Alacant
Alicante, Spain, 03012
Sponsors and Collaborators
Study Director: Eva Pineda, MD Ipsen Identifier: NCT00288522     History of Changes
Other Study ID Numbers: A-92-52030-164
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: April 2007

Additional relevant MeSH terms:
Thyroid Diseases
Eye Diseases
Graves Ophthalmopathy
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents