Longitudinal Quantitative Anterior Chamber Cell Analysis Following Vamikibart Intravitreal Therapy in Patients with Uveitic Macular Edema from the DOVETAIL Clinical Trial

Abstract

Purpose : Anterior Chamber (AC) cells may indicate active intraocular inflammation. The purpose of this analysis was to quantitatively evaluate AC cells in the DOVETAIL phase I clinical trial in patients with uveitic macular edema (UME) treated with vamikibart (anti-interleukin 6 [IL-6] monoclonal antibody, RG6179).

Methods : DOVETAIL is a phase 1, multicenter, non-randomized, open-label, multiple ascending dose study to investigate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic profile of intravitreal (IVT) vamikibart in patients with diabetic macular edema and UME. This analysis provides preliminary data from the UME cohort. Patients with UME (n=37) received 3 monthly intravitreal injections and were followed post-treatment until Week 36. Anterior segment optical coherence tomography (AS-OCT) scans were performed and longitudinal assessment of semi-automated quantitative AC cell measurements was applied. The total number of cells divided by the volume of the imaged AC was used to compute the cell density and the longitudinal change in cell density after treatment was assessed.

Results : Thirty-two patients (32 eyes) had AS-OCT scans with adequate quality and were included in the analysis (figure). Preliminary assessment suggested reduction in quantitative AC cell density following treatment with vamikibart.

Conclusions : This analysis demonstrated promising preliminary results confirming the feasibility of quantitative measurement of AC cells on AS-OCT analysis in an UME clinical trial and indicated reduction in AC cell density in eyes undergoing anti-IL-6 IVT treatment. Future analyses are needed to further characterize these changes in the entire study population once the trial has completed, as well as a more detailed assessment to investigate the differences in clinician grading decisions and the quantitative cell density measurements.

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

 

Representative images from patients with various degrees of anterior chamber inflammation seen as hyperreflective dots in the anterior chamber on single line scan optical coherence tomography scans. A: severe inflammation, B: moderate inflammation, C: mild inflammation, D: minimal inflammation.