Status:
COMPLETED
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
Lead Sponsor:
New England Retina Associates
Conditions:
Choroidal Melanoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
To report preliminary results on safety and tolerability of intravitreal injection of Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green (ICG)-based photodynami...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00680225
Start Date
September 1 2007
End Date
July 1 2012
Last Update
April 12 2017
Active Locations (1)
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1
New England Retina Associates
Hamden, Connecticut, United States, 06518