Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 3/30/2013 |
| Start Date: | July 2010 |
| End Date: | August 2012 |
| Contact: | Rosalie Caraballo |
| Email: | rc.nerastudies@gmail.com |
| Phone: | 2032882020 |
Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma
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.
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.
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