Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT00765921
Phase
PHASE1
Status
Completed

Conditions

  • Choroidal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ranibizumab — DRUG
    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).

Study Details

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.

Key Dates

First listed
Oct 3, 2008
Start date
Jun 30, 2008
Status verified
Dec 2016
Primary completion
Feb 29, 2016
Completion
Sep 30, 2016

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1.0 mg ranibizumab
    1.0 mg intravitreal injection given bi-monthly for 22 months
  • Experimental: 0.5 mg ranibizumab
    0.5 mg intravitreal injection given bi-monthly for 22 months

Primary Outcome Measure

incidence and severity of ocular adverse events and systemic adverse events [ Time Frame: 12 months and 24 months after initial treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye & Ear InfirmaryBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts Eye & Ear Infirmary· Boston, MA

Related Studies