Enhanced ellipsoid integrity, greater outer retinal thickness, and decreased GA were associated with increased BCVA gains with risuteganib.
New findings from a post-hoc analysis suggest that baseline optical coherence tomography (OCT) features may help determine the odds of a functional response to risuteganib in individuals with dry age-related macular degeneration (AMD).
Nearly 50% of eyes in the treatment arm demonstrated treatment response, compared to approximately 7% in the sham group.
“The characterization of higher-order OCT features may provide important information regarding biomarkers for treatment response and could facilitate optimized clinical trial enrollment and enrichment,” wrote study author Justis P. Ehlers, MD, Department of Ophthalmology, Cleveland Clinic.
The study set out to perform a post-hoc analysis to explore the effect of baseline anatomic characteristics identified on OCT on best-corrected visual acuity (BCVA) responses to risuteganib from a completed phase II study in patients with dry AMD. The phase II study was randomized, double-masked, and placebo controlled.
The subjects included in the study were eyes with intermediate dry AMD with BCVA between 20/40 and 20/200. It excluded patients with concurrent vision-influencing or macula-obscuring ocular pathologies.
The study participants were randomized to receive a 1-mg intravitreal risuteganib injection or a sham injection at baseline. At week 16, a second 1-mg intravitreal injection of risuteganib was given to those in the treatment arm. Two independent, masked reading centers evaluated the baseline anatomic characteristics on OCT in order to explore features associated with positive responses to risuteganib.
Main outcome measures for the study includued treatment response, defined as a gain of ≥8 letters in BCVA from baseline to week 28 in the treatment arm, compared with baseline to week 12 in the sham group. Additionally, anatomic parameters, measured by retinal segmentation platforms, including measures of retinal thickness were compared between the responders and nonresponders to risuteganib.
A total of 39 patients completed the study and underwent analysis. Within the treatment arm, investigators observed 48% of eyes demonstrated treatment responses, compared with 7% in the sham group. Then, in the quantitative anatomic assessment, enhanced ellipsoid integrity, greater outer retinal thickness, and decreased geographic atrophy were associated with increased BCVA gains to risuteganib.
The abstract, “Impact of Baseline Quantitative OCT Features on Response to Risuteganib for the Treatment of Dry Age-Related Macular Degeneration: The Importance of Outer Retinal Integrity,” was published in Ophthalmology Retina.