An Open-Label Phase Ib Study to Evaluate Retinal Imaging After Short-term Use of the Balance Goggles System (BGS) in Patients with Glaucoma

Abstract

Purpose : To determine whether the intraocular pressure (IOP)-lowering effects of BGS are accompanied by changes in retinal thickness measured by ocular coherence tomography (OCT, Cirrus, Zeiss), retinal vascular density measured by ocular coherence tomography angiography (OCTA, Cirrus, Zeiss), or retinal flavoprotein fluorescence (FPF) measured by a fundus camera (OcuMet Beacon, OcuSciences).

Methods : This is an open-label trial of up to 10 study participants with glaucoma or ocular hypertension (clinicaltrials.gov NCT04035239). Participants with qualifying study eye(s) after screening and baseline evaluations received a baseline evaluation including retinal imaging, then 1 hour of negative pressure application through the BGS, then repeat retinal imaging. Participants then used the BGS at home for 3-6 weeks, and were then imaged for a third time. The primary endpoints were safety, as assessed through adverse events (AEs) and serious adverse events (SAEs). The exploratory outcome measures were changes in ganglion cell complex layer, nerve fiber layer thickness, vascular parameters, retinal fluorescence and IOP, each measured as change from baseline at 1 hour and at 3-6 weeks.

Results : Initial enrollment demographics were 50% female, mean age of 51 years (range 25-76), and a majority diagnosed with open-angle glaucoma. No AEs were recorded at the 1-hour time point, and no SAEs were recorded through to the 3-6 week time point. The most common AEs at 3-6 weeks were transient ocular pain and headaches, and all AEs resolved at the end of the study. Retinal imaging including OCT, OCTA and FPF data showed high variability at baseline and no changes in retinal nerve fiber layer thickness at early time points.

Conclusions : The BGS was safe and sufficiently tolerated by subjects. Although additional data mining on advanced retinal imaging from this initial cohort is warranted, these data establish an acceptable safety profile to support further investigation with larger cohorts of patients over a longer follow-up period.

This is a 2020 ARVO Annual Meeting abstract.