Twelve-Month Safety and Visual Acuity Outcome of a Pilot Study Exploring Ranibizumab Combined With Proton Beam Irradiation as Treatment for Exudative Age-Related Macular Degeneration

摘要

Purpose: : To investigate the safety and tolerability of ranibizumab combined with low dose proton beam irradiation (PBR) in treating eyes with exudative age-related macular degeneration (eAMD). Methods: : Six eyes (6 subjects) with eAMD (4 newly diagnosed; 2 previous treated with ranibizumab) were treated with four monthly ranibizumab injections and 24 GyE PBR (2 fractions, 24 hrs apart). Subjects were seen monthly thereafter and retreated with ranibizumab for decrease in best refracted ETDRS visual acuity (BCVA) of 2 lines, new macular hemorrhage or fluid noted on optical coherence tomography (OCT). Results: : BCVA at enrollment ranged from 20/40 to 20/250. At month 12, BCVA was a?￥ 20/40 with improvement of a?￥ 3 lines in four of five eyes that remained enrolled. One eye exited the study at month 4 but returned with a stable Snellen VA without further treatment at month 12. Among four eyes with newly diagnosed eAMD, three eyes had no fluid on OCT at month 12 with no further treatment and one eye required 2 additional ranizbizumab injections for mild recurrent macular edema. Among two eyes previously treated with ranibizumab, both continued to require frequent retreatment with ranibizumab for recurrent or increasing fluid on OCT. One eye of these eyes which had persistent subretinal fluid at enrollment after 23 prior ranibizumab injections had progressive vision loss with enlargement of choroidal neovascular membrane and increasing subretinal fluid despite almost monthly ranibizumab treatment. No radiation retinopathy or other adverse effect was seen in any eye. Conclusions: : Combination of ranibizumab with PBR appears to be well tolerated short term in this pilot study. A potential sustained treatment effect was noted in eyes with newly diagnosed eAMD. Study is on-going to evaluate the long-term effect of this treatment. Clinical Trial: : www.clinicaltrials.gov NCT00517010.