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

Completed · Phase 3

Conditions studied: Choroidal Melanoma

In brief

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.

Key facts

Study ID

NCT00680225

Run by

New England Retina Associates

People needed

10

Starts

2007-09-01

Expected to finish

2012-07-01

Last updated by the study team

2017-04-12

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• New England Retina Associates — Hamden, Connecticut, United States

Full record on ClinicalTrials.gov

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