Pilot study of SOM230 for Treatment of Graves’ Ophthalmopathy
- Conditions
- Diseases of the eye and adnexa
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1. Male or female patients between 18 and 80 years of age
2. Patients with active GO demonstrated by
- Clinical activity score >3
- Patient who have shown at least one symptom and sign within one of the NOSPECS class 2, 3 and 4
- Abnormal value of TSH receptor antibody (IU/L) : evidence of Graves’ disease
3. Patients with a known history of failure to respond to glucocorticoid treatment for control of active inflammation of GO may be included
4. Patients with stable euthyroidism are required. Patients who are in medication of antithyroid drugs (carbimazole, benzylthiouracil, and propylthiouracil) may be included, as long as the dosage is not significantly modified during the study.
5. Patients with topical products (articial tears, ocular lubricants, and antibiotic eye drops) may be included.
6. Patients who underwent thyroidectomy and are given exogenous T4 at the appropriate dosage are permitted.
7. Patients for whom written informed consent to participate in the study has been obtained. Patients will need to provide their informed consent prior to starting any medication.
1. Illiteracy, Foreigner who can't understand Korean language
2. Patients who have being treated with systemic steroids, or other immunosuppressive agents within the previous 4 weeks.
3. Patients who have undergone eye/orbital surgery/ surgical therapy for any cause within 1 months
4. Patients who are being or were treated with octreotide, lanreotide or dopamine agonist and who have received pasireotide (SOM230) prior to this study
5. Patients who have received orbital radiotherapy within the previous 4 weeks
6. Patients who are not in active inflammatory state (CAS 3 or less) of GO
7. Patients who are presenting typical symptoms and signs of GO, but are not presenting symptoms and signs of Graves’ disease or not having abnormal value of anti-thyroid antibody such as TSH receptor antibody (no evidence of Graves’ disease)
8. Patients with symptomatic chlelithiasis
9. Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by Hb1ac >8%
10. Patients with abnormal coagulation (PT and /or aPTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (protrombin time) or aPTT (activated partial thromboplasin time)
11. Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
12. Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTc > 450 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, and taking concomitant medications known to prolong QT interval.
13. Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or patients with ALT and/or AST more than 2 x ULN(upper limit), serum creatinine > 2.0 x ULN, serum bilirubin > 2 x ULN, serum albumin < 0.67 x LLN(lower limit)
14. Patients with WBC (white blood cell) <3 x 109/L; Hgb (hemoglobin) <13 g/dL for males and <12 g/dL for females; PLT (platelet) <100 x 109/L
15. Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator
16. Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use barrier contraception with condoms. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study and for 3 months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)
17. History of immunocompromise, including a positive HIV test result (ELISA and Western blot). An HIV test will not be required; however, previous medical history will be reviewed.
18. Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to first dosing
19. Known hypersensitivity to somatostatin analogues or any other component of the
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of sucessful treatment (CAS and NOSPECS)
- Secondary Outcome Measures
Name Time Method Proptosis;diplopia;PF (palpebral fissure);TSHR Ab;CT volume;Questionaire