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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Peter E. Liggett, New England Retina Associates
ClinicalTrials.gov Identifier:
NCT01251978
First received: November 30, 2010
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Choroidal Melanoma
Drug: Ranibizumab 2 mg
Drug: 0.5 mg Ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma

Resource links provided by NLM:


Further study details as provided by New England Retina Associates:

Primary Outcome Measures:
  • 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 using the incidence and severity of adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    We are going to evaluate if the patients develop adverse events such as: Branch retinal vein occlusions, decreased visual acuity or cystoid macular edema. It is important to determine the local control of the tumor.


Secondary Outcome Measures:
  • Tumor destruction or reduction as documented by fundus photography, fluorescein angiography and ultrasonographic imaging. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Demonstrate that after the treatment period the tumor is controlled with a flat shape, no leakage shown in the fluorescein angiogram and an increased internal reflectivity in the ultrasound.


Enrollment: 10
Study Start Date: July 2010
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01251978

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

Additional Information:
No publications provided

Responsible Party: Peter E. Liggett, Principal Investigator, New England Retina Associates
ClinicalTrials.gov Identifier: NCT01251978     History of Changes
Other Study ID Numbers: FVF4927s
Study First Received: November 30, 2010
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New England Retina Associates:
Choroidal melanoma
Ranibizumab
Transpupillary Thermotherapy
CSTIP
Indocyanine Green

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 August 01, 2014