Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

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Brief Title

Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

Official Title

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

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Uveal Melanoma

Intervention

Ranibizumab


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

400

Start Date

April 2007

Completion Date

April 2009


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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Carol L Shields, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00540930

Organization ID

07-816



Study Sponsor

Shields, Shields and Associates


Study Sponsor

Carol L Shields, MD, Principal Investigator, Wills Eye Institute


Verification Date

October 2007