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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New England Retina Associates
• Treatments: Ranibizumab

Criteria

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.