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

• Status: Completed
• Trial end date: 2017-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborator: University of California, San Francisco
• Treatments: Bevacizumab

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