Aflibercept Injection Reduced Complications in Diabetic Retinopathy Trial
By Adam Hochron
April 14, 2021
An NIH-sponsored clinical trial evaluating aflibercept injection in patients with moderate-to-severe non-proliferative diabetic retinopathy without center-involved diabetic macular edema found that after two years, patients saw a 68% reduced risk of developing vision-threatening complications.
According to a release from the manufacturer, patients who received the medication fared better than those who received sham injections who reported nearly five times more disease progression. The Protocol W trial included patients who were randomized to receive either aflibercept every 16 weeks, after receiving initial doses at weeks 0, 4, 8, and 16, or a sham dose. Patients who enrolled had “excellent vision” at the start of the trial, with most having 20/20 vision or better. The rescue therapy was given if patients developed proliferative diabetic retinopathy or center-involved diabetic macular edema.
In addition to being less likely to develop the complications, the release noted that patients treated with the medication were three times more likely to experience a two-step improvement in their DR severity score and five times less likely to require rescue therapy due to the complications.
The release noted that at the two-year time point of the Protocol W trial, patients treated with the drug as a preventive injection did not show a significant difference in visual acuity compared to delayed treatment after complications. However, the company cited a follow-up analysis of the PANORAMA trial, which found that delaying the treatment resulted in three times as many patients experiencing prolonged vision loss compared to those receiving the preventive treatment.
While there were no new safety signals identified, three patients in the drug arm experienced endophthalmitis. The rate of cardiovascular/cerebrovascular adverse events was “not significantly different” among the treatment groups.
The Protocol W trial is expected to continue for two more years when researchers will assess visual acuity outcomes between the two groups after four years.