Status:
UNKNOWN
Efficacy Study of Lucentis in the Treatment of Retinoblastoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Retinoblastoma
Eligibility:
All Genders
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01899066
Start Date
July 1 2013
End Date
December 1 2015
Last Update
May 13 2014
Active Locations (1)
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1
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, +8620