Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

Status unconfirmed · Phase 4

Conditions studied: Uveal Melanoma, Radiation Retinopathy, Radiation Maculopathy

In brief

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 facts

Study ID

NCT00540930

Run by

Shields, Shields and Associates

People needed

400

Starts

2007-04-01

Expected to finish

2009-04-01

Last updated by the study team

2007-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Wills Eye Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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