Phase 1 Pilot Open Label Prospective Observational Study of Safety and Tolerability of Lucentis Combined With Proton Beam Irradiation in Treating Exudative Age-related Macular Degeneration
Five subjects diagnosed with wet macular degeneration will be treated with standard of care,
i.e. intravitreal Lucentis injection monthly for the first four months and as needed
thereafter. Within six weeks of the first Lucentis injection, the eye will also be treated
with 24 Gy of proton beam divided into two fractions. Each subject will be followed for 2
yrs with monthly examination.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence and severity of ocular adverse events, as identified by eye examination at 12 and 24 months will be determined.
12 and 24 months
Susanna S Park, MD PhD
University of California, Davis
United States: Food and Drug Administration