Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma

New England Retina Associates1 site in 1 country10 target enrollmentSeptember 2007

ConditionsChoroidal Melanoma

InterventionsRanibizumab injection and TTT - ICG based

DrugsRanibizumab injection and TTT - ICG based

Overview

Phase: Phase 3
Intervention: Ranibizumab injection and TTT - ICG based
Conditions: Choroidal Melanoma
Sponsor: New England Retina Associates
Enrollment: 10
Locations: 1
Primary Endpoint: Mean Tumor Thickness
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 photodynamic therapy (PDT) in the treatment of choroidal melanoma.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

July 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

New England Retina Associates

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Lucentis Injection

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.

Intervention: Ranibizumab injection and TTT - ICG based