Efficacy Study of Lucentis in the Treatment of Retinoblastoma

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Brief Title

Efficacy Study of Lucentis in the Treatment of Retinoblastoma

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

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

all cause mortality

Secondary Outcome

 Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma

Condition

Retinoblastoma

Intervention

Lucentis, chemotherapy

Study Arms / Comparison Groups

 Lucentis; chemotherapy
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

July 2013

Completion Date

December 2015

Primary Completion Date

December 2015

Eligibility Criteria

        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.)
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Huasheng Yang, +8620-87331539, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01899066

Organization ID

yanghs20130627


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

Huasheng Yang, Study Chair, Sun Yat-sen University


Verification Date

May 2014