Research, reported in EURETINA’s professional journal, Ophthalmologica, has shown that a treat-and-extend (“TAE”) regimen using aflibercept for typical AMD appears effective for improving AMD and exudative changes. In addition the investigators commented that the exudation observed in participants may be suppressed with fewer treatments in classic choroidal neovascularisation (CNV), compared to occult CNV. The research, conducted by investigators at the Department of Ophthalmology, Gunma University School of Medicine, Japan, was motivated by the relatively rare number of publications testing treat-and-extend regimens of aflibercept on treatment naïve exudative AMD patients.
In general, anti-VEGF agents may be delivered at fixed intervals, monthly or bimonthly, while common regimens in clinical use include both reactive pro re nata (PRN) regimens and proactive treat-and-extend regimens. Sponsor led pivotal trials of MARINA and ANCHOR described monthly appointments and injections however, in practical terms, clinicians and patients may preferentially opt for treatments with fewer appointments and injections, especially in terms of evaluating patient burden and medical costs. To test if such burdens could be reduced further, researchers in the current study analysed a total of 76 patients (77 eyes) who underwent a treat-and-extend regimen using intravitreal injections of aflibercept between November 2013 and October 2014. The researchers examined 60 patients (61 eyes; 47 men [48 eyes] and 13 women [13 eyes]) with a mean age of 73.1 (range: 57–90) years, who were able to continue the treatment for at least 2 years. According to the researchers, the treat-and-extend regimen used in the study involved 3 monthly 2-mg aflibercept injections in the loading phase, followed by prolongation of the injection interval by 2 weeks if no exudative changes were seen, or shortening of the injection interval by 2 weeks if exudative changes were seen in the maintenance phase. Exudative changes were defined as new hemorrhage detected by fundus examination or subretinal fluid or intraretinal edema detected by OCT. The minimum and maximum injection intervals were set at 4 and 12 weeks.
The study measured the best-corrected visual acuity (BCVA), central macular thickness (CMT), central choroidal thickness (CCT), number of injections, and complications during the 24-month period of the study. Following completion, the results indicated that BCVA had significantly improved by on average 0.13 logMAR units, and CMT and CCT had significantly decreased. The average number of injections used was 13.6 and, in the second year, eyes with classic CNV needed significantly fewer treatments than eyes with occult CNV. Fourteen eyes, which developed subfoveal fibrosis, showed significantly poorer BCVA after 2 years. In conclusion, the Japanese research group commented that, “a TAE regimen using IVA (intravitreal aflibercept) for (typical) AMD might be effective for improving BCVA and exudative changes. The exudation may be suppressed with fewer treatments in classic CNV compared to occult CNV.”