prospectivetrial of proton beam combined with anti-vegf therapy for exudative age-related macular degeneration (amd)

Conditions: Exudative Age-related Macular Degeneration

Summary: the purpose of this study is to test the hypothesis that proton beam irradiation combined with intravitreal anti-vegf therapy is safe and potentially more effective than intravitreal anti-vegf therapy alone in eyes with exudative age-related macular degeneration.

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.

Eligibility criteria:
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

Keywords: exudative age-related macular degeneration proton beam irradiation ranibizumab bevacizumab anti-vegf therapy