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A study that evaluated the safety and feasibility of treating ophthalmic artery stenoses with angioplasty in patients with late-stage age-related macular degeneration (AMD) with geographic atrophy (GA) showed reported observing efficacy and functional improvement in this patient population,1 according to Pedro Lylyk, MD, and colleagues. Lylyk is from Interventional Neuroradiology, Instituto Medico Equipo de Neurocirugía Endovascular y Radiología Intervencionista, Buenos Aires.
They reported their results in the Journal of Neurointerventional Surgery.
The investigators explained that a significant correlation was found between progression of AMD and the volumetric blood flow in the ophthalmic artery (P=0.002).2 They also cited a retrospective study in which stenosis of the ophthalmic artery was confirmed and treated with angioplasty on a compassionate use basis in patients with late-stage AMD. Despite the end-stage disease, visual improvements occurred.3
“Although it is known that the development of AMD includes both genetic and environmental factors, the discovery of ophthalmic artery stenoses is recognized as a treatable environmental stressor in this complex disease process. If left untreated, it continues to provide a relentless source of chronic ischemia, exacerbating the development and progression of late-stage AMD,” they commented.
They explained further that “choriocapillaris flow deficits accumulate preferentially within the central macula with age,4,5 and the extent of macular choriocapillaris deficits is correlated with the growth of GA in patients with late-stage AMD. This suggests that ocular perfusion is associated with disease progression.”
The authors conducted a prospective multicenter study that included 17 patients with confirmed late-stage AMD with GA, ophthalmic artery stenosis, and systemic stability.
Ophthalmic artery angioplasty was performed using an investigational ophthalmic percutaneous transluminal catheter system (OcuDyne) designed for this novel anatomic target and indication for use; the system included an aiming microcatheter and a micro-balloon catheter.The 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. The patients were followed for 3 months by the interventional neuroradiology site and 6 months by the ophthalmology site, the investigators recounted.
Eleven (64.7%) patients were successfully treated with ophthalmic artery angioplasty using the investigational ophthalmic percutaneous transluminal catheter system.
Procedure-related adverse events 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 adverse events, ie, suspected retinal microemboli and potential reperfusion injury, were asymptomatic, graded as mild, and resolved without treatment or sequelae.
“The mean ± standard deviation) primary lesion stenoses decreased 59% from 43.7% ± 14.25% to 18.2% ± 12.09%. At the study exit, the 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,” Lylyk and colleagues reported.
The investigators commented on their results.
“This study adds to the body of knowledge by confirming the safety and feasibility of the procedure in a controlled clinical setting. In addition, insight into the potential to resuscitate declining retinal cellular health has been gained. The hyperfluorescent reflex that produces a penumbra surrounding the GA is broadly thought to be a reflection of declining retinal function and cellular health due to the chronic ischemic environment. If these cells are rejuvenated by the study treatment and maintained by perfusion restoration, it makes sense that it would result in the efficacy that was demonstrated. Objective outcomes included an increase in choroidal thickness in all subjects and a mean improvement that was statistically significant. Subjectively, visual and functional improvements were also demonstrated. Moreover, the subjects themselves reported improved mobility as well as reading and accessing information, via a validated questionnaire.”
Lylyk and colleagues believe that their results provide guidance for future study in this area.
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