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

New England Retina Associates

Status and phase: Completed; Phase 3

Conditions: Choroidal Melanoma

Treatments: Drug: Ranibizumab injection and TTT - ICG based

Study type: Interventional

Funder types: Other

Identifiers

NCT00680225

FVF4290s

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Lucentis Injection

Experimental group

Description:

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.

Treatment:

Drug: Ranibizumab injection and TTT - ICG based