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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter E. Liggett, New England Retina Associates
ClinicalTrials.gov Identifier:
NCT00680225
First received: May 15, 2008
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680225

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

No publications provided

Responsible Party: Peter E. Liggett, Principal Investigator, New England Retina Associates
ClinicalTrials.gov 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
Lucentis
TTT-ICG

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 17, 2014