active severe endocrine orbitopathy MedDRA version: 12.1 Level: LLT Classification code 10066617 Term: Graves' ophthalmopathy worsened MedDRA version: 12.1 Level: LLT Classification code 10014702 Term: Endocrine exophthalmos MedDRA version: 12.1 Level: LLT Classification code 10015684 Term: Exophthalmos endocrine MedDRA version: 12.1 Level: LLT Classification code 10043787 Term: Thyrotoxic exophthalmos MedDRA version: 12.1 Level: LLT Classification code 10057889 Term: Graves' ophthalmopathy
Conditions
Interventions
Trade Name: Solu-Medrol
Product Name: Solu-Medrol
Product Code: not applicable
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 03/03/2375
Other descriptive name: METHYLP
Sponsors
Insitute of Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pacients with active and moderate to severe or sight threatening endocrine orbitopathy (EO), age more than 18 years, laboratory positivity of autoantibodies against TSH receptor, patological monitored parameters for the ultrasonographical examination of the orbit. Activity is maesured on the classical features on inflamantion: clinical activity score (CAS). CAS more tahn 4 indicates active EO. Moderate to severe EO: Patients usualy have any one or more of the following: lid retraciton more than 2 mm, moderate or severe soft tissue involvement, exophthalmos more than 3 mm above normal for race and gender, inconstant, or constant diplopia. Sight threatening EO: Patients with dysthyroid optic neuropathy and/or corneal breakdown. Monitored parameters for the ultrasonographic examination of the orbit: thickness of the medial, lateral and inferior direct eye muscle and thickness of the upper muscle group - superior direct with eyelid levator - lateral and inferior, according to an arbitrary scale established by us the muscle echogenicity - I to IV, where I is a normal orbital muscle, i.e. deeply hypoechogeneic, IV is of the echogenicity as high that it is barely undistinguishable from surrounding connective tissue. Measurement of the flow rates especially in the arteria centralis retinae, artheries cilliares breves and in artheria ophthalmica. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: hypersensitivity, TBC (patients with active disease and latent disease, including positive tuberculin test, which need careful monitoring for possibility of reactivation of disease and requirements of chemoprophylaxis), systemic mycosis, active peptic ulcer, fresh intestinal anastomoses, decompensated diabetes mellitus, severe heart insuficiency, severe uncorrected hypertension, psychosis (acute or in medical history), severe impairment of renal function, active hepatitis, gravidity, lactation, inability to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the project is to find laboratory, clinical and ultrasonographic markers usable for the prediction of the response on intravenous GC administration in severe endocrine orbitopathy and to elucidate the differences in the treatment effect among individual patients.;Secondary Objective: To improve the efficiency of the treatment and diagnostics in patients with severe endocrine orbitopathy ;Primary end point(s): The characteristics of particular clinical, laboratory and ultrasonographic markers for prediction of response to iv glucocorticoid administration | — |
Countries
Czech Republic
Outcome results
None listed