Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma

Study Overview
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Brief Summary
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To report preliminary results on safety and tolerability of intravitreal injection of Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.

Official Title
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Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma

Conditions
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Choroidal Melanoma

Intervention / Treatment
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* Drug: Ranibizumab injection and TTT - ICG based


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 yo. Primary pigmented or amelanotic choroidal melanoma measurement of 16 mm or less in the largest vessel diameter and 6 mm or less in the apical height. Location of the tumor posterior to the equator. Documented growth by A/B scan. Risk factor for metastasis (thickness greater than 2 mm, symptoms, tumor margin at the optic disc) Ability to provide inform consent. Comply with the study assessment for the cooperation of the study. Exclusion Criteria: Pregnancy or lactation. Premenopausal women not using adequate contraception; surgical sterilization or use of oral contraception, barrier contraception with either a condom or diaphragm or in conjunction with spermicidal gel, an IUD or contraceptive hormon implant or patch. Current infection or inflammation in either eye. Extension of tumor into the orbit. Retinal 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: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucentis Injection<br>Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month. | Drug: Ranibizumab injection and TTT - ICG based<br>* Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.<br>* Other names: Lucentis injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Tumor Thickness |  | 12 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity Changes |  | 12 mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choroidal melanoma, Lucentis, TTT-ICG