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Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)

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.
 
ClinicalTrials.gov Identifier: NCT01251978
Recruitment Status : Completed
First Posted : December 2, 2010
Results First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
New England Retina Associates

Study Description
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Brief Summary:
Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.

Condition or disease Intervention/treatment Phase
Choroidal Melanoma Drug: Ranibizumab 2 mg Drug: 0.5 mg Ranibizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma
Study Start Date : July 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: High dose Ranibizumab
6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart.
 Drug: Ranibizumab 2 mg
intravitreal injections of ranibizumab once a month, times 3.
Active Comparator: Standard Dose Ranibizumab
6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
 Drug: 0.5 mg Ranibizumab
6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.


Outcome Measures
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Primary Outcome Measures :
  1. To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Tumor Thickness [ Time Frame: baseline and 1 year ]
  2. Visual Acuity (LogMar) [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height.
  • Location of the tumor, posterior to the equator of the eye.
  • Documented growth of tumor by A-B scan.
  • Ability to provide written informed consent and comply with the study assessment for the full duration of the study.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Premenopausal women not using adequate contraception.
  • Current infection or inflammation in either eye.
  • Extension of tumor into the orbit.
  • Regional 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
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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): NCT01251978


Locations
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United States, Connecticut
New England Retina Associates
Hamden, Connecticut, United States, 06518
Sponsors and Collaborators
New England Retina Associates
Genentech, Inc.
Investigators
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Principal Investigator: Peter E Liggett, MD New England Retina Associates
More Information
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Additional Information:

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Responsible Party: New England Retina Associates
ClinicalTrials.gov Identifier: NCT01251978    
Other Study ID Numbers: FVF4927s
First Posted: December 2, 2010    Key Record Dates
Results First Posted: October 19, 2016
Last Update Posted: October 19, 2016
Last Verified: October 2016
Keywords provided by New England Retina Associates:
Choroidal melanoma
Ranibizumab
Transpupillary Thermotherapy
CSTIP
Indocyanine Green
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents