GRAVES' ORBITOPATHY MedDRA version: 16.0 Level: LLT Classification code 10057889 Term: Graves' ophthalmopathy System Organ Class: 100000004853
Conditions
Interventions
Trade Name: SOLUMEDROL
Product Name: SOLUMEDROL
Product Code: 83-43-2
Pharmaceutical Form: Powder and solution for solution for injection
Trade Name: SOLUMEDROL
Product Name: SOLUMEDROL
Product Code:
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with recent onset of signs of DON with at least two of the following: - definite disc swelling - definite RAPD - loss of colour vision (>2/6 errors at HRR plates) - reduced BCVA (less than Logmar 0.0 or pre disease BCVA) 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 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age under 18 yrs - Active viral hepatitis, - elevated liver enzymes (4 times upper normal limits) - other active chronic infection - Severe heart disease (unstable angina, or recent (within previous 6 months) acute coronary syndrome, or heart failure worse than class 2 NYHA); - severe systemic hypertension (hypertension requiring more than 4 antihypertensive drugs to maintain control); uncontrolled hypertension=>180/110; - Uncontrolled diabetes (HbA1c > 8% ) - Active peptic ulcer - Pregnancy - Lack of effective contraception in fertile women - lack of mental capacity, significant psychiatric illness / inability to obtain informed consent - Presence of other neurological or ophthalmological (cataract, glaucoma, AMD, etc) diseases that could significantly affect visual function - Previous orbital surgery in the affected eye/eyes. - Previous unresponsiveness to IVMP for DON. - More than 2g of MP in the previous 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Adequate recovery of visual function (when at least 3 of the following are present), assessed at one and 3 months : - BCVA = 0.7 (logmar 0,18) or two lines within pre DON values - =than three errors on HRR - Disc swelling recovered - Visual field MD improved of at least 3dB compared to baseline or MD > - 6 Db The primary endpoint will be assessed at 1 and 3 months ;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed at 1 and 3 months ;Main Objective: To test the efficacy and safety of two different dosages of pulsed iv methylprednisolone for the treatment of dysthyroid optic neuropathy (DON): regimen 1) 1g of MP administered daily for 3 consecutive days, for 2 consecutive weeks, tapered off with 8 infusion of 250 mg of MP (cumulative dose= 8g) regimen 2) 500 mg of MP administered daily for 3 consecutive days, for 2 consecutive weeks, tapered off with 8 infusion of 250 mg of MP (cumulative dose= 5g) ;Secondary Objective: 1. Safety and tolerability of the two therapeutic protocols. 2. Factors influencing clinical response 3. Improvement in quality of life 4. Inactivation of GO (CAS = 2) 5. Need for additional surgical treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adequate recovery of visual function (when at least 3 of the following are present), assessed at one and 3 months : - BCVA = 0.7 (logmar 0,18) or two lines within pre DON values - =than three errors on HRR - Disc swelling recovered - Visual field MD improved of at least 3dB compared to baseline or MD > - 6 Db The secondary end point will be assessed at 6 months ;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Belgium, France, Germany, Italy, Switzerland
Contacts
Public ContactNICOLA CURRO'
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO MILANO
Outcome results
None listed