EFFICACY OF STEROIDS IN THE TREATMENT OF DYSTHYROID OPTIC NEUROPATHY

• Conditions: GRAVES' ORBITOPATHY; MedDRA version: 16.0Level: LLTClassification code 10057889Term: Graves' ophthalmopathySystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-001196-20-IT
• Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO MILANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-07
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified