A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related Macular Degeneration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- University of Florida
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Visual acuity per comprehensive eye exam
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a pilot study to determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane (SNVM). The study will include adult patients over the age of 50 with macular degeneration, who have subfoveal neovascularization membrane (SNVM) and have had prior treatment with Avastin or Lucentis. Additional purposes of this study are to see if the growth of neovascular membranes can be stopped and overall vision improved with the use of protons and assess the side effects associated with this treatment.
Detailed Description
As part of this study, participants will have had a standard of care comprehensive eye exam by an Ophthalmologist to include visual acuity, fundus photography, fluorescein angiography and optical coherence tomography prior to treatment. Participants will receive radiation using protons for 2 consecutive days. Each treatment will take 30 minutes. They will receive a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments. A total of 10 participants will be enrolled on this study. A comprehensive eye exam by an Ophthalmologist will be performed 30 days after radiation treatment with protons. Additionally, a physical examination per a Radiation Oncologist including a toxicity evaluation and comprehensive eye exam by an Ophthalmologist will be performed every 3 months for 1 year following radiation treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with subfoveal neovascular membranes identified on fluorescein angiography.
- •Visual acuity (best corrected vision) 20/200 or worse in affected eye.
- •Patient must be 50 years of age or older at time of consent.
- •Patients must have had prior treatment for macular degeneration with Avastin (bevacizumab) or Lucentis (ranibizumab).
- •Women must be post menopausal or have had a hysterectomy.
Exclusion Criteria
- •History of diabetes.
Outcomes
Primary Outcomes
Visual acuity per comprehensive eye exam
Time Frame: 1 year after completion of radiation treatment
Number of participants with cessation of growth of neovascular membranes.
Time Frame: 1 year after completion of radiation treatment
Frequency of intravitreal injections following radiation treatment
Time Frame: 1 year after completion of radiation treatment
Number of participants with acute and late morbidity of the eye as a measure of safety
Time Frame: 1 year after completion of radiation treatment