Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)

New England Retina Associates

Status and phase

Completed

Phase 2

Conditions

Choroidal Melanoma

Treatments

Drug: Ranibizumab 2 mg

Drug: 0.5 mg Ranibizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01251978

FVF4927s

Details and patient eligibility

About

Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.

Enrollment

10 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years or older
Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height.
Location of the tumor, posterior to the equator of the eye.
Documented growth of tumor by A-B scan.
Ability to provide written informed consent and comply with the study assessment for the full duration of the study.

Exclusion criteria

Pregnancy or lactation.
Premenopausal women not using adequate contraception.
Current infection or inflammation in either eye.
Extension of tumor into the orbit.
Regional 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.