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Clinical Trials/NCT00540930
NCT00540930
Unknown
Phase 4

A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma

Shields, Shields and Associates1 site in 1 country400 target enrollmentApril 2007

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Uveal Melanoma
Sponsor
Shields, Shields and Associates
Enrollment
400
Locations
1
Primary Endpoint
Presence or absence of optical coherence (OCT) evidence of macular edema.
Last Updated
18 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
April 2009
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shields, Shields and Associates

Eligibility Criteria

Inclusion Criteria

  • Age \>18 years
  • new diagnosis of choroidal melanoma
  • scheduled for plaque radiotherapy at Wills Eye Health System

Exclusion Criteria

  • Pre-existing retinal disorders (i.e. age-related macular degeneration, diabetic maculopathy, retinal vascular occlusion, macular hole, surface wrinkling retinopathy)
  • prior retinal detachment
  • media opacities precluding accurate OCT imaging
  • history of glaucoma
  • pregnancy
  • age \<18 years.

Outcomes

Primary Outcomes

Presence or absence of optical coherence (OCT) evidence of macular edema.

Time Frame: 4 months

Secondary Outcomes

  • Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.(4 months)

Study Sites (1)

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