Baseline characteristics did not affect outcomes of PULSAR study
Click Here to Manage Email Alerts
SEATTLE — The effects of aflibercept treatment in the three arms of the PULSAR study were not affected by baseline characteristics, according to four subgroup analyses presented at the American Society of Retina Specialists annual meeting.
In PULSAR, patients with treatment-naive wet age-related macular degeneration were randomly assigned to three arms, receiving aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks or aflibercept 2 mg every 8 weeks, all after three initial monthly injections. The primary endpoint was visual acuity at week 48.
Image: Adobe Stock
In the first subgroup analysis, patients were categorized according to baseline best corrected visual acuity of 54 ETDRS letters or less, between 55 and 73 letters, or 74 letters or more.
“No matter what the baseline vision is, the absolute vision is going to be the same among all three arms [at week 48],” Keyvan Koushan, MD, FRCSC, said.
Due to an expected ceiling effect, patients with better vision at the beginning had less absolute improvement of vision.
The second subgroup analysis was based on baseline central subfield thickness (CST) of less than 400 µm or 400 µm or greater.
“Like in the previous subgroup analysis, the improvement in vision and the absolute vision were similar, no matter which baseline CST,” Koushan said.
Another subgroup analysis was based on baseline choroidal neovascularization lesion type, classified as classic, occult only or predominantly classic.
“Regardless of the lesion type, the absolute vision at the end of 48 weeks was similar among all three arms of the study,” Koushan said.
Finally, a subgroup analysis based on race, namely white and Asian, showed that regardless of the race of the patients, the absolute vision at the end of the study was similar among all three arms.
When looking at the proportion of patients maintained at q12 and q16, “you can see that the majority of patients, almost 80%, were able to maintain the q12 or q16, and that also holds true for white patients and Asian patients,” he said.
Collapse
Koushan K, et al. Subgroup analyses from the phase 3 PULSAR trial of aflibercept 8 mg in patients with treatment-naïve neovascular age-related macular degeneration. Presented at: American Society of Retina Specialists annual meeting; July 28-Aug. 1, 2023; Seattle.
Read more about
Click Here to Manage Email Alerts