Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Phase 1

Completed

• Conditions: Choroidal Melanoma
• Interventions: Drug: ranibizumab

• Registration Number: NCT00765921
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2016-02
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.0 mg ranibizumab	ranibizumab	1.0 mg intravitreal injection given bi-monthly for 22 months
0.5 mg ranibizumab	ranibizumab	0.5 mg intravitreal injection given bi-monthly for 22 months

Primary Outcome Measures

Name	Time	Method
incidence and severity of ocular adverse events and systemic adverse events	12 months and 24 months after initial treatment

Secondary Outcome Measures

Name	Time	Method
incidence of radiation-induced complications, vision loss and eye loss	12 months and 24 months after initial treatment

Trial Locations

Locations (1)

Massachusetts Eye & Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States