The evaluation of ophthalmic artery lesions in the treatment of geographic atrophy

Abstract

Purpose : Stenoses of the ophthalmic artery (OA) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) may contribute to disease progression in AMD. Validation of this mechanism of disease progression requires the ability to accurately and reproducibly evaluate lesions in the OA that effect ocular perfusion. In this ongoing open-label safety and feasibility study (NCT05091476), we developed imaging and grading methodologies to assess the extent of OA stenoses both before and after artery balloon angioplasty.

Methods : This study enrolled patients ≥60 years old with best-corrected visual acuity <56 letters (<20/80) due to GA secondary to AMD and with evidence of OA stenosis. Procedural feasibility, defined as successful OA canulation and balloon angioplasty with demonstrative change to the artery lumen, is a primary endpoint of this study. Preoperatively, eligibility screening of subjects was performed using magnetic resonance angiography (MRA). Intraoperatively, pre- and post-procedural 2D and 3D digital subtraction angiography (DSA) were performed, as well as exploratory collection of perfusion mapping, mean aneurysm flow amplitude (MAFA), and choroidal blush outcomes. Evaluations of the stenoses were conducted using recorded images and p-values calculated using a single-tailed, paired analysis.

Results : Nine lesions in the first six consecutively treated subjects are reported. Four subjects presented with a single lesion, 1 subject presented with two lesions, and 1 subject with three lesions. Of the nine lesions, 4 presented with >25.0% and <40% stenoses, two had 40.0% – <50.0% stenoses, two had 50.0% – < 60.0% stenoses, and one presented with 60.0% – <70.0% stenosis. Stenoses presented as either focal (Figure 1, top) or diffuse (Figure 1, bottom). Mean (SD) pre-procedural stenosis of 43.92% (12.73) was decreased to 21.63% (9.16) (Figure 2), representing a 50.8% (p = 0.001) decrease in mean stenosis.

Conclusions : From the ostium to the central retinal branch bifurcation, the OA is an imaging challenge due to the its small caliber, its anatomical complexity, and the tortuosity along its path. With the imaging modalities presented here, we demonstrate the potential to identify clinically relevant OA stenoses and the ability to effect change in the target anatomy.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.