Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

Thyroid-Associated Ophthalmopathy Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00288522
• Other study ID #: A-92-52030-164
• Secondary ID: 2004-003937-14
• Status: Terminated
• Phase: Phase 2
• Start date: January 2006
• Est. completion date: April 2007

Study information

• Verified date: June 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid-Associated Ophthalmopathy

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital General d'Alacant	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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