Abstract
Purpose: :
To evaluate the safety and tolerability of ranibizumab combined with low dose proton beam irradiation in treating exudative age-related macular degeneration (AMD).
Methods: :
An investigator-sponsored, open-labeled, prospective observational case series of subjects with exudative AMD treated with four monthly ranibizumab injection combined with a single course of 24 Gy proton beam irradiation (2 fractions, 24 hrs apart) administered during the first month. Subjects were seen monthly thereafter and ranibizuamb was administered as needed for any new decrease in best corrected visual acuity of 2 or more lines or any subretinal fluid or macular edema noted on optical coherence tomography.
Results: :
Three eyes with newly diagnosed exudative AMD and one eye with recurrent macular edema after previous treatment with ranibizumab were enrolled. Best corrected visual acuity before treatment ranged from 20/40 to 20/125. At six months follow-up, best corrected visual acuity was greater than 20/40 in all eyes; no treatment-related adverse effect was noted in any of the eyes. Among eyes with newly diagnosed exudative AMD, visual acuity improved over 15 letters in all eyes and no additional ranibizumab injection was necessary during the seven month follow-up period.
Conclusions: :
Combination of ranibizumab with low dose proton beam irradiation appears to be well tolerated short-term in this small pilot study. Excellent visual outcome and sustained treatment effect was noted among eyes with newly diagnosed exudative AMD. Studies are on-going to evaluate the long-term effect of this combination therapy.
Clinical Trial: :
www.clinicaltrials.gov NCT00517010
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • drug toxicity/drug effects