NCT00765921

Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.

Conditions

• Choroidal Melanoma

Interventions

Type	Name	Description
DRUG	ranibizumab	Ranibizumab dose of 0.5mg or 1.0 mg will be administered intravitreally at the time of surgery for tumor localization and then bimonthly for 22 months (total of 12 injections).

Timeline

• Start date: 2008-06-01
• Primary completion: 2016-02-01
• Completion: 2016-09-01
• First posted: 2008-10-03
• Last updated: 2016-12-02

Locations

1 site across 1 country: United States