Ophthalmic artery angioplasty in a cohort of patients with geographic atrophy secondary to non-exudative age-related macular degeneration.

Abstract

Background: There is increasing evidence that vascular disease and chronic perfusion deficits play a role in the progression of age-related macular degeneration (AMD). This controlled clinical study evaluated the safety and feasibility of treating patients with late-stage AMD and associated geographic atrophy (GA). In addition, exploratory endpoints evaluated the potential to disrupt the disease process and initiate functional changes.

Methods: A total of 17 subjects with confirmed late-stage AMD with GA, ophthalmic artery stenosis, and systemic stability were enrolled in this prospective multicenter study. Eleven (64.7%) of these subjects were successfully treated with ophthalmic artery angioplasty using an investigational ophthalmic percutaneous transluminal catheter system designed for this novel anatomical target and indication for use. Primary endpoints included procedure-related complications and procedural feasibility. All exploratory analyses were focused on ophthalmic outcomes and assessed for potential efficacy in choroidal thickness, visual acuity, reading ability, and patient-reported outcomes. Treated subjects were followed for 3 months by the interventional neuroradiology site and for 6 months by the ophthalmology site.

Results: All systemic procedure-related adverse events (AEs) were potentially expected, effectively treated, resolved without sequelae, and included bronchial abrasion and hemoptysis secondary to intubation, urinary tract infection secondary to urinary catheterization, and vascular access site inflammation and hematoma. Procedure-related ocular AEs (eg, suspected retinal microemboli and potential reperfusion injury) were asymptomatic, graded as mild, and resolved without treatment or sequelae. Mean (SD) primary lesion stenoses decreased 59% from 43.7 (14.25)% to 18.2 (12.09)%. At study exit, mean best-corrected visual acuity improved by 6.7 letters (P=0.003) over baseline, and reading ability results improved 3.4%, 5.1%, and 28.5% (P=0.03) over baseline for reading acuity, critical print size, and reading speed, respectively. Patient-reported outcomes showed improvements in mobility and independence and in reading and accessing information.

Conclusions: The feasibility of ophthalmic artery angioplasty in this population was demonstrated with the investigational devices, while providing an acceptable safety profile. Efficacy and functional improvement were also seen, providing guidance for future study.