Aflibercept Treat-and-Extend Effective for nAMD, PCV in Real-World Practice

Yi-Ting Hsieh, MD

Credit: ResearchGate

A treat-and-extend regimen of 2 mg aflibercept was effective in treating neovascular age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV) in real-world practice, according to new two-year findings.¹

The retrospective review, conducted in Taiwan, revealed both anatomical and functional improvements were achieved during the two years, with an average of 11 aflibercept injections. Treatment intervals extended to 16 weeks in approximately 61% and 79% of the nAMD and PCV cases, respectively.

“Aflibercept with a treat-and-extend regimen for nAMD and PCV in real-world practice could achieve favorable outcomes comparable to those reported in clinical trials,” wrote the investigative team, led by Yi-Ting Hsieh, MD, of the department of ophthalmology, National Taiwan University Hospital.

Prior study data have shown aflibercept treat-and-extend with an interval of up to 16 weeks to be effective in the treatment of AMD and PCV in clinical trials.² However, a treatment interval >16 weeks has been rarely reported in real-world clinical practice. For this analysis, Hsieh and colleagues assessed two-year, real-world results among patients with nAMD or PCV treated with a treat-and-extend aflibercept regimen after 3 monthly loading doses.¹

Biomarkers on optical coherence tomography (OCT), including intraretinal fluid (IRF), subretinal fluid (SRF), and the presence of pigmented epithelial detachment (PED), are often used to predict visual outcomes after nAMD treatment. Investigators sought to assess biomarkers using OCT to improve their prediction of aflibercept treatment outcomes. The medical records of patients treated for ≥2 years at the National Taiwan University Hospital between January 2016 and March 2022 were retrospectively reviewed for analysis.

According to the study treatment criteria, if best-corrected visual acuity (BCVA) remained stable with <1 line loss and no fluid on OCT after the loading phase, intervals were extended by 2 to 4 weeks. If the retina was not completely dry, but fluid remained stationary, intervals were maintained. If there was an increase in fluid, new hemorrhage, or BCVA loss for ≥1 line, treatment intervals were shortened.

Investigators collected clinical data at baseline, including BCVA, number of injections, treatment intervals, as well as OCT biomarkers, including central macular thickness (CMT), the presence of SRF, and serous PED. Data were additionally collected at 3, 6, 12, 18, and 24 months after the first injection. The study enrolled 43 patients, including 24 with AMD and 19 with PCV, with a mean age of 69.4 years.

Upon analysis, investigators found no significant differences in baseline characteristics between the nAMD and PCV groups (P >.05), except for a higher proportion of SRF in the PCV group (84.2%; P = .026).

After 3 loading injections, the overall mean BCVA significantly improved from 0.75 ± 0.41 logMAR at baseline to 0.60 ± 0.41 logMAR at 3 months after treatment initiation (P = .002). Similar improvements in vision were observed in both the PCV and nAMD groups.

Vision improvement was maintained up to 12 months with a mean BCVA of 0.61 ± 0.45 logMAR (P = .038), but the BCVA gradually declined to 0.66 ± 0.46 at 24 months, showing no further significant visual improvement (P = .14). Anatomical outcomes showed the mean CMT significantly decreased from baseline at 3 months after loading treatment and remained stable at 12 and 24 months (P <.001).

Analyses showed the mean number of injections during the treatment course was 7.07 ± 1.28 at 12 months and 10.95 ± 2.65 at 24 months, respectively. Those in the PCV group received fewer injections than the nAMD group at 24 months (P = .006). At 24 months of treat-and-extend, the interval was extended to ≥16 weeks in 60.5% of all cases and 78.9% of the PCV cases.

Data on OCT biomarkers found the presence of persistent IRF at 3 months was associated with worse BCVA at 24 months (P = .050). The presence of SRF at 24 months was associated with worse BCVA (P = .004). Hsieh and colleagues noted those with persistent SRF at 3 months tended to have more injections and a shorter treatment interval at 24 months (P = .026 and P = .005, respectively).

“These results demonstrate that persistent SRF after the loading phase indicates a more refractory course that necessitates more frequent injections; however, vision could be maintained if the SRF resolved after aggressive treatment with the treat-and-extend regimen,” they wrote.

References

1. _{Huang CH, Lai TT, Yang CH, Hsieh YT. Two-Year Real-World Results for Aflibercept Using the Treat-and-Extend Regimen in Neovascular Age-Related Macular Degeneration and Polypoidal Choroidal Vasculopathy. Ophthalmol Ther. Published online November 23, 2023. doi:10.1007/s40123-023-00850-6}
2. _{Ohji M, Takahashi K, Okada AA, et al. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial. Adv Ther. 2020;37(3):1173-1187. doi:10.1007/s12325-020-01236-x}