Active thyroid-associated ophtalmopathy of moderate intensity.
Conditions
Interventions
Trade Name: Somatulina Autogel ® 60 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: lanreotide
Current Sponsor code: 52030
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
IPSEN PHARMA, S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient must give written or oral (with witnesses) informed consent prior to any study-related procedure. - Patients from both genders and over 18 years of age - Patients with autoinmune thyroid disease and whose center's medical records confirm the presence of euthyroidism for at least two months before being included into the study. - Thyroid-associated ophtalmopathy diagnosed a minimum of six months before his/her participation in the study, well documented in the centre's medical records. - The intensity of thyroid-associated ophtalmopathy in the worst eye has to be moderate and based on the following criteria: Two or more of the following criteria: • Modified Clinical Activity Score (CAS)(1) 1-2 • Subclinic optical neuropathy (abnormal visual evoked potentials) • Lid width incremented with superior sclerocorneal limbo and visible adjacent sclerotic • Inttermitent diplopia • Proptosis =20 mm and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - The patient presents compressive optical neuropathy signs or risk of corneal perforation which require immediate surgical treatment. - The patient presents thyroid-associated ophtalmopathy diagnosed as serious based on the following critera: • Modified CAS>4 • Visual acuity 2 mm of visible superior sclerotic • Proptosis>23 mm • Permanent diplopia with the gaze's primary position - The patient has been treated with radio-iodine for his/her thyroid disturbance within the 6 months previous to the inclusion in the trial. - The patient's thyroid-associated ophtalmopathy has been treated previously (except for drops and local measures) or he is scheduled to be treated during the study time (except for the study medication). - The patient is planned to be treated with radio-iodine or thyroidectomy for his/her Grave's disease during the study. - Myopia, glaucoma or any other eye disease which could modify the ophtalmologycal progress, such as cataracts or macule degeneration. - The patient is a smoker of more than 5 cigarettes per day. - the patient is included in other trial. - Breast-feeding or pregnant women (beta-HCG will be measured before the patients are included) or high risk of getting pregnant due to inadequate contraceptive measures. - Patients receiving any unlicensed drug within the 30 previous days to the start of the study. - Patients previously entered in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: To evaluate the efficacy and safety of 3 doses of Somatuline Autogel (60 mg) in the control of the infiltration and edema of the muscle and retrobulbar connective tissue and in the retraction and contraction of the extraocular musculature in patients with active thyroid-associated ophtalmopathy of moderate intensity. ;Primary end point(s): To assess the oedema and the infiltration of the extraocular muscles and connective tissue measuring the extraocular muscle size by using orbital computerized tomography, to assess the proptosis by using a Hertel's exophthalmometer and measuring the intraocular pressure with a Perkin's tonometer. To assess the retraction and contraction of the extraocular musculature measuring the palpebral retraction assessed by the visual exam of the upper sclereocorneal limbo and visible adjacent sclerotic; and the function of the extraocular musculature evaluated by the Hess Weiss's diagram (for motility) and with the Maddox cross (for diplopia). | — |
Countries
Spain
Outcome results
None listed