Ophthalmic artery angioplasty improves visual acuity in patients with geographic atrophy

Abstract

Purpose : Geographic atrophy (GA) is the most advanced and disabling form of dry age-related macular degeneration (AMD) and with or without currently available treatments, the patient loses 5 letters of vision per year on average. While age and genetic variants are strongly associated with the pathogenesis of AMD, environmental factors play a crucial role. One environmental factor is localized macular ischemia, and this may be exacerbated by stenotic lesions in the ophthalmic artery (OA). An ongoing open-label safety and feasibility study (NCT05091476) is testing the use of OA angioplasty to treat GA.

Methods : This study enrolled patients ≥60 years old with Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) <56 letters (20/80 or worse) due to GA. These patients were diagnosed with OA stenosis and treated with balloon angioplasty (Figure 1). BCVA was obtained at baseline and at postoperative weeks 1 and 4. Data are reported as letters read and total letter gain by subject and visit.

Results : These results include the first six consecutively treated subjects that have completed Week 4. The subjects include 3 (50%) male, mean age (SD) of 72.3 (8.45), and baseline mean (SD) ETDRS BCVA of 31.2 (19.8) letters (range, 5 – 55); mean Snellen BCVA of 20/240 (range, 20/800 – 20/80). All subjects are Caucasian, 5 (83.3%) report a familial history of AMD, 4 (66.7%) report a history of smoking with a mean (SD) of 14.0 (16.12) smoking years. At one week, mean ETDRS BCVA improved by 5.3 letters to 36.5 and to 38.8 letters at 4 weeks. These data represent a mean (SD) ETDRS letter gain of 7.7 (6.28), range 3 – 18, at Week 4 (Figure 2, top). All subjects demonstrated improved VA at Week 1. One subject declined at Week 4; however, all maintained improvement over baseline (Figure 2, bottom). Additional reports of subjective improvement in visual quality immediately after the procedure were expressed as changes in metamorphopsia, color vision, contrast, and visual field.

Conclusions : In this case series, balloon angioplasty of stenoses in the OAs resulted in improved BCVA in subjects with GA. Though longer follow-up is needed and additional patients are being recruited, these preliminary data support further investigation of balloon angioplasty for OA stenoses in AMD patients with GA.

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

 

Figure 1: Ophthalmic Artery Angioplasty Procedure

 

Figure 2: Mean Letter Gain by Visit (top) and by Subject (bottom)