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

This study has been completed.
Information provided by (Responsible Party):
Peter E. Liggett, New England Retina Associates Identifier:
First received: May 15, 2008
Last updated: May 1, 2013
Last verified: May 2013
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.

Condition Intervention Phase
Choroidal Melanoma
Drug: Ranibizumab injection and TTT - ICG based
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma

Resource links provided by NLM:

Further study details as provided by New England Retina Associates:

Primary Outcome Measures:
  • Reduction in tumor size [ Time Frame: 3 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity changes [ Time Frame: 3 mo ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Name: Lucentis injection


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00680225

United States, Connecticut
New England Retina Associates
Hamden, Connecticut, United States, 06518
Sponsors and Collaborators
New England Retina Associates
  More Information

Responsible Party: Peter E. Liggett, Principal Investigator, New England Retina Associates Identifier: NCT00680225     History of Changes
Obsolete Identifiers: NCT00541528
Other Study ID Numbers: FVF4290s 
Study First Received: May 15, 2008
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New England Retina Associates:
Choroidal melanoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Physiological Effects of Drugs processed this record on May 26, 2016