Overview

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