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.
Verified date | June 2020 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General d'Alacant | Alicante |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
Spain,
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 |
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