Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

This study is currently recruiting participants.
Verified December 2013 by Massachusetts Eye and Ear Infirmary
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00765921
First received: October 2, 2008
Last updated: December 17, 2013
Last verified: December 2013

October 2, 2008
December 17, 2013
June 2008
December 2015   (final data collection date for primary outcome measure)
incidence and severity of ocular adverse events and systemic adverse events [ Time Frame: 12 months and 24 months after initial treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00765921 on ClinicalTrials.gov Archive Site
incidence of radiation-induced complications, vision loss and eye loss [ Time Frame: 12 months and 24 months after initial treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Choroidal Melanoma
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with newly diagnosed choroidal melanoma undergoing proton therapy
  • Tumors >15 mm in largest diameter and/or >5 mm in height (recruitment complete)
  • Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula
  • 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
Both
18 Years and older
No
Contact: Joyce Galonsky, BSN 617-573-4382 joyce_galonsky@meei.harvard.edu
United States
 
NCT00765921
07-06-040, FVF4384s
No
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Genentech
Principal Investigator: Ivana Kim, M.D. Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
December 2013

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