Researchers Take an Overview Approach to nAMD Treatment Burden and Vision Analysis

July 28, 2020
Kenny Walter

The mean number of injections in the studies over 12 months was 9.36 ± 2.66, with a mean change in ETDRS letters was 7.86 ± 1.37.

While Anti-VEGF medications have revolutionized treatment for neovascular age-related macular degeneration (nAMD), there is still some uncertainty as to what the optimal dosing regimen ultimately is.

In a new trial presented at the American Society of Retina Specialists (ASRS) 2020 Virtual Meeting, a team, led by Rahul Komati, MD, reviewed level 1 evidence on anti-vascular endothelial growth factor (anti-VEGF) injection patterns for neovascular age-related macular degeneration to determine the optimal dosing regimen.

When analyzing anti-VEGF agents, more injections have yielded better vision in clinical trials. However, this can often come with a high cost of treatment burden on both patients and providers.

In the study, the investigators reviewed the Level 1 evidence of currently approved anti-VEGF agents, as well as those likely to undergo review by regulatory authorities. The researchers analyzed the anti-VEGF agents and treatment dosing regimen for each study and collected the baseline ETDRS letters, mean number of injections over a 12-month period, and change in ETDRS letters over the course of 12 months.

They analyzed a total of 23 injection regiments from studies involving 6860 eyes, including 8 (31.6%, n = 2165) involving ranibizumab every 4 weeks or pro re nata and 6 (28.6%; n = 1962) involving aflibercept dosed every 4 or 8 weeks.

In addition, there were 4 (15.4%; n = 1059) studies involving abicipar every 8 or 12 weeks, 3 (15.8%; n = 1088) involving brolucizumab dosed every 12 or 8 weeks based on clinical activity, and 2 (8.7%) involving bevacizumab every 4 weeks or PRN.

The mean number of injections in the studies over 12 months was 9.36 ± 2.66, with a mean change in ETDRS letters was 7.86 ± 1.37. The correlation coefficient between the number of injections and the mean change in ETDRS letters was 0.60.

“Despite the varying durability of the different anti-VEGF agents, there is a positive and clinically meaningful correlation between the number of injections in 12 months and the change in mean BCVA (ETDRS letters),” the authors wrote. “Retina specialists should utilize this data in real-world practice, while considering the impact of treatment burden on neovascular AMD patients.”

In a separate trial presented during ASRS 2020, investigators found intravitreal anti-VEGF is associated with greater rates of cognitive impairment in nAMD patients.

The interim findings could come as a raised concern for the retina care community, as millions of intravitreal anti-VEGF administrations are given annually to a mostly older patient population.

Noting a direct communication between the CNS and vitreous across multiple pathological states, investigators sought to interpret the actual effect anti-VEGF injection therapy may have on the cognitive health of patients with nAMD.

The 72 patients with <20 injections reported significantly healthier BHA scores than the 44 with ≥20 injections. Investigators also noted a greater likelihood of cognitive impairment among patients with ≥20 injections than those with fewer.

The study, “Treatment Burden and Vision Analysis of Anti-VEGF Therapies for the Treatment of Neovascular AMD,” was published online by ASRS 2020.