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Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma

Phase 3
18 Years
90 Years
Not Enrolling
Choroidal Melanoma

Thank you

Trial Information

Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction in tumor size

Outcome Time Frame:

3 mo

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

July 2012

Related Keywords:

  • Choroidal Melanoma
  • Choroidal melanoma
  • Lucentis
  • Melanoma



New England Retina Associates Hamden, Connecticut  06518