Efficacy Study of Lucentis in the Treatment of Retinoblastoma

Lucentis in the Treatment of Retinoblastoma - A Phase II, Single Center, Randomized Study to Evaluate the Efficacy of Ranibizumab in Subjects With Retinoblastoma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01899066

Enrollment

Registered

2013-07-15

Start date

2013-07-31

Completion date

2015-12-31

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinoblastoma

Keywords

Efficacy

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 .

Interventions

DRUGLucentis, 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.

DRUGchemotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactHuasheng Yang, M.D, PHD

yanghs64@126.com+8620-87331539

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026