Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
Overview
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.
Full Title of Study: “Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: July 2012
Interventions
- Drug: Ranibizumab 2 mg
- intravitreal injections of ranibizumab once a month, times 3.
- Drug: 0.5 mg Ranibizumab
- 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.
Arms, Groups and Cohorts
- Active Comparator: High dose Ranibizumab
- 6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
- Active Comparator: Standard Dose Ranibizumab
- 6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
Clinical Trial Outcome Measures
Primary Measures
- To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
- Time Frame: 1 year
Secondary Measures
- Tumor Thickness
- Time Frame: baseline and 1 year
- Visual Acuity (LogMar)
- Time Frame: 12 months
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: 90 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- New England Retina Associates
- Collaborator
- Genentech, Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Peter E Liggett, MD, Principal Investigator, New England Retina Associates
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