Data from a phase 2 study is suggesting risuteganib could be a safe and effective treatment for improving vision in patients with non-exudative(dry) age-related macular degeneration.
Results of the study, which were presented by David Boyer, MD, at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting in San Francisco, revealed nearly half of the patients involved in the trial achieved an increase of 8 or more letters of best-corrected visual acuity(BCVA) at 48 weeks.
“The primary endpoint was met. From baseline to week 12, 7.1% of the sham group gained 8 letters or more versus 48% from baseline to week 28,” said Boyer, a physician with Retina-Vitreous Associates Medical Group.
In an effort to assess the safety and efficacy of a 1.0 mg dose of intravitreal risuteganib, investigators designed a prospective, randomized, double-masked, placebo-controlled phase 2 study examining use in patients with intermediate non-exudative age-related macular degeneration. A total of 45 patients were recruited for the study and 42 were included in the final analyses.
Inclusion criteria for the study included having non-exudative AMD with a BCVA between 33 and 72 ETDRS letters, being symptomatic of decreases in visual acuity in the last year, have evidence of well-preserved areas of RPE and well-defined RPE and out segment ellipsoid line. Patients were also required to have a combination of RPE disturbances, 1 or more large druse(greater than 125 microns), or multiple intermediate drusen(62 to 124 microns) in the macula.
Patients that met inclusion criteria for the study were randomized to receive either risuteganib or a sham injection at baseline and again at 16 weeks. A total of 25 patients were included in the risuteganib group while 14 were included in the sham group. Due to study design, patients were allowed to switchover to risuteganib at week 16.
Upon analyses, investigators found the 20% of patients in the risuteganib group achieved a gain of 8 letters or more in BCVA from baseline to week 12 and 48% reached the threshold at week 28. For comparison, just 7.1% (P=0.013) of patients in the sham group achieved a gain of 8 letters or more at 12 weeks. Additionally, in the crossover group, that rate improved to 14.3% from week 16 to week 28.
Boyer noted there were no serious systemic serious adverse events and no ocular serious events occurred as a result of risuteganib use. He also pointed out 1200 injections have been given outside of the study.
“In conclusion, risuteganib is a small synthetic peptide that regulates integrin function. In phase 2 it met its primary end point,” Boyer said.
This study, “Primary Results from Phase 2 Study of Risuteganib (RSG) in Intermediate Dry AMD,” was presented at AAO 2019 by David Boyer, MD.