Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

Phase 2

Terminated

• Conditions: Thyroid-Associated Ophthalmopathy

• Registration Number: NCT00288522
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-08
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Hospital General d'Alacant; 🇪🇸 Alicante, Spain