Status:
COMPLETED
Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Choroidal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 fo...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed choroidal melanoma undergoing proton therapy
- Tumors \>15 mm in largest diameter and/or \>5 mm in height
- Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye
Exclusion
- History of prior treatment for choroidal melanoma
- Pregnancy or lactation
- Presence of diabetic retinopathy
- History of retinal vascular occlusion or other retinal vascular disease
- Active ocular inflammation or history of uveitis in either eye
- History of uncontrolled glaucoma (defined as intraocular pressure \>30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
- Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days.
- Concurrent use of systemic anti-VEGF therapy
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00765921
Start Date
June 1 2008
End Date
September 1 2016
Last Update
December 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, United States, 02114