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

Overview

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.

Full Title of Study: “Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2012

Interventions

  • Drug: Ranibizumab injection and TTT – ICG based
    • 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.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Mean Tumor Thickness
    • Time Frame: 12 mo

Secondary Measures

  • Visual Acuity Changes
    • Time Frame: 12 mo

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • New England Retina Associates
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.