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Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Shields, Shields and Associates.
Recruitment status was:  Active, not recruiting
Information provided by:
Shields, Shields and Associates Identifier:
First received: October 5, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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 Intervention Phase
Uveal Melanoma Radiation Retinopathy Radiation Maculopathy Drug: Ranibizumab Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Shields, Shields and Associates:

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

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

Estimated Enrollment: 400
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT00540930

United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Shields, Shields and Associates
Principal Investigator: Carol L Shields, MD Wills Eye Institute
  More Information Identifier: NCT00540930     History of Changes
Other Study ID Numbers: 07-816
Study First Received: October 5, 2007
Last Updated: October 5, 2007

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on August 17, 2017