Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New England Retina Associates
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• 18 years or older

• Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height.

• Location of the tumor, posterior to the equator of the eye.

• Documented growth of tumor by A-B scan.

• Ability to provide written informed consent and comply with the study assessment for the full duration of the study.

Exclusion Criteria:

• Pregnancy or lactation.

• Premenopausal women not using adequate contraception.

• Current infection or inflammation in either eye.

• Extension of tumor into the orbit.

• Regional spread or metastatic disease.

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.

• Any known allergy to any of the components to be used in the study.

• Participation in another simultaneous medical investigation or trial.