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