Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
NCT ID: NCT00680225
Last Updated: 2017-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
10 participants
INTERVENTIONAL
2007-09-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lucentis Injection
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.
Ranibizumab injection and TTT - ICG based
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.
Interventions
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Ranibizumab injection and TTT - ICG based
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
Yes
Sponsors
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New England Retina Associates
OTHER
Responsible Party
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Locations
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New England Retina Associates
Hamden, Connecticut, United States
Countries
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Other Identifiers
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FVF4290s
Identifier Type: -
Identifier Source: org_study_id
NCT00541528
Identifier Type: -
Identifier Source: nct_alias
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