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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01899066
Other study ID # yanghs20130627
Secondary ID
Status Recruiting
Phase Phase 2
First received July 3, 2013
Last updated May 10, 2014
Start date July 2013
Est. completion date December 2015

Study information

Verified date May 2014
Source Sun Yat-sen University
Contact Huasheng Yang, M.D, PHD
Phone +8620-87331539
Email yanghs64@126.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Lucentis, chemotherapy
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
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.

Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary all cause mortality measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years two years No
Secondary 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. two years No
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