Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Choroidal Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765921
• Other study ID #: 07-06-040
• Secondary ID: FVF4384s
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2008
• Last updated: December 1, 2016
• Start date: June 2008
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Melanoma
• Melanoma

Intervention

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).

Locations

Country	Name	City	State
United States	Massachusetts Eye & Ear Infirmary	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of ocular adverse events and systemic adverse events		12 months and 24 months after initial treatment	Yes
Secondary	incidence of radiation-induced complications, vision loss and eye loss		12 months and 24 months after initial treatment	No