ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)

Radiation combined with anti-VEGF therapy has been shown to be synergistic in treating cancer and result in sustained tumor regression. On-going clinical trials have shown potential synergism between intravitreal anti-VEGF therapy and epiretinal brachytherapy administered during vitrectomy surgery in treating eyes with exudative age-related macular degeneration (eAMD). In this study, we test the hypothesis that radiation to the macula administered noninvasively via proton beam is well-tolerated in eyes with eAMD when combined with intravitreal anti-VEGF therapy and that this combination therapy may act synergistically to result in sustained treatment effect in eyes with eAMD.

Inclusion criteria

• Subjects will be eligible if the following criteria are met:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 50 years
• Patient related considerations
• Able to maintain follow-up for at least 24 months.
• Women must be postmenopausal without a period for at least one year.
• Diagnosed with Age-related Macular Degeneration (ARMD) with active subfoveal choroidal neovascular membrane (CNVM), newly diagnosed or treated with first dose of anti-VEGF therapy within 6 weeks of enrollment
• Visual acuity 20/40 to 20/400
• Lesion size < 12 Disc Area
• Submacular hemorrhage less than 75% of total lesion and not involving foveal center
• Submacular fibrosis less than 25% of total lesion
• Candidate for intravitreal anti-VEGF therapy

Exclusion criteria

• Subjects who meet any of the following criteria will be excluded from this study:

• Prior enrollment in the study
• Pregnancy (positive pregnancy test) or lactation
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial
• Previous treatment with Photodynamic Therapy (PDT) or thermal laser in study eye
• Anti-VEGF therapy within 6 weeks
• Intravitreal or subtenon's Kenalog within 6 months
• Intraocular surgery within 3 months or expected in the next 6 months
• Current or planned participation in other experimental treatments for wet AMD
• Other concurrent retinopathy or optic neuropathy
• Other causes of CNVM, i.e. myopic degeneration or ocular histoplasmosis (POHS)
• Significant media opacity precluding adequate view of the fundus for exam, photography or OCT
• History of radiation therapy to the head or study eye
• Diabetes mellitus or hemoglobin A1c > 6
• Head tremor or h/o claustrophobia precluding positioning for proton irradiation
• Inability to maintain steady fixation with either eye
• History of Malignancy treated within 5 years
• Allergy to Fluorescein dye