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Efficacy Study of Lucentis in the Treatment of Retinoblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01899066
Recruitment Status : Unknown
Verified May 2014 by Huasheng Yang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : July 15, 2013
Last Update Posted : May 13, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Retinoblastoma Drug: Lucentis, chemotherapy Drug: chemotherapy Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lucentis in the Treatment of Retinoblastoma - A Phase II, Single Center, Randomized Study to Evaluate the Efficacy of Ranibizumab in Subjects With Retinoblastoma
Study Start Date : July 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.

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.

Other Name: Ranibizumab
Active Comparator: chemotherapy
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Drug: chemotherapy
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.
Other Names:
  • vincristine;
  • carboplatin;
  • etoposide.

Outcome Measures

Primary Outcome Measures :
  1. all cause mortality [ Time Frame: two years ]
    measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years

Secondary Outcome Measures :
  1. Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899066

Contact: Huasheng Yang, M.D, PHD +8620-87331539 yanghs64@126.com

China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, +8620
Contact: Huasheng Yang, MD,PHD    +862087331539    yanghs64@126.com   
Sponsors and Collaborators
Sun Yat-sen University
Study Chair: Huasheng Yang Sun Yat-sen University
More Information

Responsible Party: Huasheng Yang, Efficacy Study of Lucentis in the Treatment of Retinoblastoma, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01899066     History of Changes
Other Study ID Numbers: yanghs20130627
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by Huasheng Yang, Sun Yat-sen University:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors