Proton Radiation Therapy for Macular Degeneration

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related Macular Degeneration

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Radiation: Proton radiation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton radiation<br>Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments | Radiation: Proton radiation<br>* Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with acute and late morbidity of the eye as a measure of safety |  | 1 year after completion of radiation treatment | 
| Number of participants with cessation of growth of neovascular membranes. |  | 1 year after completion of radiation treatment | 
| Visual acuity per comprehensive eye exam |  | 1 year after completion of radiation treatment | 
| Frequency of intravitreal injections following radiation treatment |  | 1 year after completion of radiation treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-Related Macular Degeneration, Macular Degeneration, Proton radiation, Choroidal Neovascular Membranes