Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy

Inclusion Criteria:

1. Men and women, at least 18 years of age.
2. ECOG performance status 0 or 1.
3. Patients must have histologically confirmed stage IB to stage III primary melanoma of cutaneous origin (AJCC 7th edition classification).
4. Must complete all primary therapy (wide excision with or without lymphadenectomy).

Exclusion Criteria:

1. Mucous membrane or ocular melanoma.
2. Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening).
3. Patients with retinopathy on baseline fundoscopic examination at the start of interferon therapy.
4. History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix).
5. Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
6. Patients who have a history of depression or other psychiatric diseases requiring hospitalisation.
7. History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes),
8. Unwilling or unable to comply with the requirements of the protocol for the duration of the study.