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Lucentis as an Adjuvanct Therapy With TTT-ICG Based in Choroidal Melanoma
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Active
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18 to 90
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Other
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FVF4290s
NCT00680225
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Trial Description
Summary 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. Eligibility Criteria 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 esterilization 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.
- Participitation in another simultaneous medical investigation or trial.
Trial Contact Information
Trial Lead Organizations/Sponsors New England Retina Associates
Trial Sites
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| U.S.A. |
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| Connecticut |
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Hamden |
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| | | | | | | | | New England Retina Associates |
| | | Cindy Rokas, RN |
Ph: 203-479-6836 |
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Email:
retinastudies@hotmail.com |
| | | Veronica Kon-Jara, MD |
Ph: 2034796836 |
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Email:
retinastudies@hotmail.com |
| | | Peter E. Liggett, MD | Principal Investigator |
| | | Juner M. Colina, MD | Sub-Investigator |
| | | Veronica Kon-Jara, MD | Sub-Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00680225
Information obtained from ClinicalTrials.gov on July 16, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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