Efficacy Study of Lucentis in the Treatment of Retinoblastoma

Phase 2

• Conditions: Retinoblastoma
• Interventions: Drug: Lucentis, chemotherapy; Drug: chemotherapy

• Registration Number: NCT01899066
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-15
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-10
• Last Update Posted: 2014-05-13
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Definite characteristic signs of retinoblastoma,Group D base on Intraocular International Retinoblastoma classify, IIRC.

Exclusion Criteria

• History of surgical intervention for retinoblastoma in the study eye.
• Any previous disease in the study eye.
• Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
• Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lucentis; chemotherapy	Lucentis, chemotherapy	Lucentis: 0.5mg/0.05 ml;Other Name: Ranibizumab;monthly for the first six months. Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
chemotherapy	chemotherapy	chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.

Primary Outcome Measures

Name	Time	Method
all cause mortality	two years	measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years

Secondary Outcome Measures

Name	Time	Method
Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma	two years	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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China