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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma

Conditions
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Choroidal Melanoma

Intervention / Treatment
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* Drug: Ranibizumab 2 mg
* Drug: 0.5 mg Ranibizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose Ranibizumab<br>6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart. | Drug: Ranibizumab 2 mg<br>* intravitreal injections of ranibizumab once a month, times 3.<br>|
| Active Comparator: Standard Dose Ranibizumab<br>6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months. | Drug: 0.5 mg Ranibizumab<br>* 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Thickness |  | baseline and 1 year | 
| Visual Acuity (LogMar) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choroidal melanoma, Ranibizumab, Transpupillary Thermotherapy, CSTIP, Indocyanine Green