Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Shields, Shields and Associates
Study ID
NCT00540930
Phase
PHASE4
Status
Unknown

Conditions

  • Radiation Maculopathy
  • Radiation Retinopathy
  • Uveal Melanoma

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion

Study Details

Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving treatments can deliver equivalent life prognosis in the management of small and medium sized uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most common eye-preserving treatment in the current management of uveal melanoma, but is complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy/maculopathy need to be developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits the activity of vascular endothelial growth factor A, a mediator in the development of choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as age related macular degeneration. This study will investigate the possible benefit of Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following plaque radiation for uveal melanoma.

Key Dates

First listed
Oct 8, 2007
Start date
Apr 30, 2007
Status verified
Oct 2007
Completion
Apr 30, 2009

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Primary Outcome Measure

Presence or absence of optical coherence (OCT) evidence of macular edema. [ Time Frame: 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wills Eye InstitutePhiladelphiaPennsylvania19107-

Find similar trials in Philadelphia, PA

By research site
Wills Eye Institute· Philadelphia, PA

Related Studies