Peter Kaiser, MD, presented data from a phase 2 trial examining the safety and efficacy of risuteganib at ASRS 2019.
Peter Kaiser, MD
Results of a study examining the efficacy and safety of a potential novel therapy for the treatment of non-exudative (dry) age-related macular degeneration was presented at the 2019 American Society of Retina Specialists Annual Meeting.
Peter Kaiser, MD, of the Cole Eye Institute, presented results of a phase 2 study on Saturday, which found that patients treated with risuteganib for intermediate dAMD met the primary endpoint of 8 letters gained in visual acuity.
“Patients in the study had to have decreased vision due to something and so those would be the patients that this is useful for,” Kaiser said. “This would not be a treatment for all dry macular degeneration patients. It would be only a treatment for those patients who are having trouble with their visual acuity.”
To evaluate the efficacy and safety of risuteganib — a novel integrin inhibitor — within a group of patients with intermediate dAMD, investigators carried out a prospective, randomized, double-masked, placebo-controlled phase 2 study. A total of 45 patients from 7 sites in the US were included in the study. Inclusion criteria included a best-corrected visual acuity between 20/40 and 20/200, intermediate dAMD, and a preserved foveal outer retina and retinal pigment epithelial.
At baseline, patients were randomized to either receive 1.0 mg risuteganib or sham injection. At week 16, patients in the sham group were allowed to cross over and receive a single dose of risuteganib — those already randomized to risuteganib received a second dose.
Of the 45 patients enrolled in the study, the mean age was 76.2 years, the mean baseline BCVA was 61 letters, and 75% of the population was female. Primary endpoint for the group was change in BCVA compared to sham group and secondary endpoints included low luminance BCVA, color vision and microperimetry.
Upon analyses, investigators found that the primary endpoint, of 8 letter gain in visual acuity, was met by participants receiving risuteganib. Kaiser added that an impact on functional measures was noted. Kaiser noted that just 1 patient in the sham group met the primary endpoint of the study. Findings from analyses of secondary endpoints, which included gains of 10 and 15 letters in visual acuity, proved to be insignificant.
Kaiser also pointed out the safety profile of risuteganib, which was demonstrated during the trial through a lack of adverse events compared with sham. When asked how this novel treatment could impact primary care during a discussion, Kaiser was adamant that if safety and efficacy are proven in phase 3 trials and risugetanib is approved — it is not for every patient suffering from dAMD.
“In this phase 2 study, the primary endpoint was met in terms of patients gaining more than 8 ETDRS letters in visual acuity at the end of the study,” Kaiser said during his presentation. “Functional measures also support this and will be presented at future meetings.”
This study, titled “Safety and Efficacy of Risuteganib in Intermediate Nonexudative Age-Related Macular Degeneration: First Time Results From a Phase 2 Study,” was presented at ASRS 2019.