A phase II, unicentre, randomized, double-blind, parallel and placebo-controlled, pilot study to evaluate the efficacy and safety of Somatuline Autogel (60 mg) in patients with active thyroid-associated ophthalmopaty of moderate intensity. Estudio piloto, de fase II, unicéntrico, aleatorizado, a doble ciego, paralelo y controlado con placebo para evaluar la eficacia y seguridad de Somatulina Autogel R (60 mg) en pacientes con oftalmopatía tiroidea activa de intensidad moderada
- Conditions
- Active thyroid-associated ophtalmopathy of moderate intensity.
- Registration Number
- EUCTR2004-003937-14-ES
- Lead Sponsor
- IPSEN PHARMA, S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
- 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 <21.5
or
One or more of the following criteria
• Modified Clinical Activity Score 3-4
• Visual acuity between 0.5 and 0.9 (both included)
• Lid width incremented with superior sclerotic clearly visible and up to a maximum of 2 mm
• Proptosis 21.5 to 23 mm
• Occasional diplopia (with the gaze's secondary positions)
(1) Modified CAS: each one of the following signs is considered as one point: spontaneous retrobulbar pain, pain in the eye movements, lid erythema, conjunctival hyperemia, chemosis, caruncle inflamation, oedema of the lid.
• Patients whose ophtalmopathy activity has been demonstrated by a positive octreoscan.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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 <0.5
• Lid width incremented with >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method