Status:
COMPLETED
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
Lead Sponsor:
New England Retina Associates
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Choroidal Melanoma
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
Brief 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 numb...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01251978
Start Date
July 1 2010
End Date
August 1 2012
Last Update
October 19 2016
Active Locations (1)
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1
New England Retina Associates
Hamden, Connecticut, United States, 06518