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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00680225
First Posted: May 20, 2008
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New England Retina Associates
  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
Intervention Model: Single Group Assignment
Masking: None (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:
  • Mean Tumor Thickness [ Time Frame: 12 mo ]

Secondary Outcome Measures:
  • Visual Acuity Changes [ Time Frame: 12 mo ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680225


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

Responsible Party: New England Retina Associates
ClinicalTrials.gov Identifier: NCT00680225     History of Changes
Obsolete Identifiers: NCT00541528
Other Study ID Numbers: FVF4290s
First Submitted: May 15, 2008
First Posted: May 20, 2008
Results First Submitted: April 10, 2017
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017
Last Verified: April 2017

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
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents