NCT01899066

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 .

Conditions

• Retinoblastoma

Interventions

Type	Name	Description
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.
DRUG	chemotherapy	chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-07-15
• Last updated: 2014-05-13

Locations

1 site across 1 country: China