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Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00540930
Recruitment Status : Unknown
Verified October 2007 by Shields, Shields and Associates.
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2007
Last Update Posted : October 8, 2007
Information provided by:
Shields, Shields and Associates

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.

Condition or disease Intervention/treatment Phase
Uveal Melanoma Radiation Retinopathy Radiation Maculopathy Drug: Ranibizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma
Study Start Date : April 2007
Estimated Study Completion Date : April 2009

Intervention Details:
  • Drug: Ranibizumab
    Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion
    Other Name: Lucentis

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

Secondary Outcome Measures :
  1. Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up. [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00540930

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United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Shields, Shields and Associates
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Principal Investigator: Carol L Shields, MD Wills Eye Institute
Layout table for additonal information Identifier: NCT00540930    
Other Study ID Numbers: 07-816
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: October 8, 2007
Last Verified: October 2007
Additional relevant MeSH terms:
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Macular Degeneration
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Retinal Diseases
Eye Diseases
Retinal Degeneration
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents