This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.
This study will be a phase II open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without intravitreal ranibizumab at a dose of 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Lucentis:0.50mg/0.05ml, intravitreal injection,monthly for the first six months. chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGall cause mortality
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years
Time frame: two years
Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma
measure the tumor size and new vessels by ultrasonography，fundus photography and fundoscopy before each treatment, and 1,3,6,9,12,18,24 months after the treatment.
Time frame: two years
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