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Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

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: NCT00765921
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : December 2, 2016
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary

Tracking Information
First Submitted Date  ICMJE October 2, 2008
First Posted Date  ICMJE October 3, 2008
Last Update Posted Date December 2, 2016
Study Start Date  ICMJE June 2008
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
incidence and severity of ocular adverse events and systemic adverse events [ Time Frame: 12 months and 24 months after initial treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
incidence of radiation-induced complications, vision loss and eye loss [ Time Frame: 12 months and 24 months after initial treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
Official Title  ICMJE A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
Brief Summary The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Choroidal Melanoma
Intervention  ICMJE Drug: ranibizumab
Ranibizumab dose of 0.5mg or 1.0 mg will be administered intravitreally at the time of surgery for tumor localization and then bimonthly for 22 months (total of 12 injections).
Other Names:
  • rhuFab
  • Lucentis
Study Arms  ICMJE
  • Experimental: 1.0 mg ranibizumab
    1.0 mg intravitreal injection given bi-monthly for 22 months
    Intervention: Drug: ranibizumab
  • Experimental: 0.5 mg ranibizumab
    0.5 mg intravitreal injection given bi-monthly for 22 months
    Intervention: Drug: ranibizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2010)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2008)
20
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with newly diagnosed choroidal melanoma undergoing proton therapy
  • Tumors >15 mm in largest diameter and/or >5 mm in height
  • Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye

Exclusion Criteria:

  • History of prior treatment for choroidal melanoma
  • Pregnancy or lactation
  • Presence of diabetic retinopathy
  • History of retinal vascular occlusion or other retinal vascular disease
  • Active ocular inflammation or history of uveitis in either eye
  • History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
  • Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days.
  • Concurrent use of systemic anti-VEGF therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765921
Other Study ID Numbers  ICMJE 07-06-040
FVF4384s ( Other Identifier: Genentech )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Massachusetts Eye and Ear Infirmary
Study Sponsor  ICMJE Massachusetts Eye and Ear Infirmary
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Ivana Kim, M.D. Massachusetts Eye and Ear Infirmary
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP