This article is more than 5 years old. Information may no longer be current.
Vision gains in anti-VEGF trial lost when routine care resumes
Click Here to Manage Email Alerts
Switching patients to fixed-dosing aflibercept after as-needed treatment with ranibizumab or bevacizumab resulted in visual gain and reduction of central subfoveal thickness in a trial. However, benefits were lost through undertreatment when patients returned to routine clinical practice after release from the trial.
Within the ASSESS prospective trial performed at Cole Eye Institute, 32 patients with age-related macular degeneration were transitioned from Avastin (bevacizumab, Genentech) or Lucentis (ranibizumab, Genentech) to fixed bimonthly intravitreal Eylea (aflibercept, Regeneron) injection. Results at 2 years showed statistically significant improvement in central subfoveal thickness and vision when compared with baseline. In the following year, patients were managed according to routine clinical practice, mostly with an as-needed regimen.
The 18 patients who completed the third year had a mean of eight follow-up visits and a mean of 3.7 injections. During the third year, visual acuity decreased by 5.1 ETDRS letters from month 24 and central subfoveal thickness increased by 11.9 mm. Twenty-two percent of patients had visual acuity of 20/200 or worse at baseline, which was reduced to 5.5% at month 24 but increased to 16.7% at month 36.
“As patients were transitioned back to a routine clinical regimen, there was no significant improvement in the burden related to the number of clinic visits,” the authors noted. “Additionally, the loss of visual and anatomical improvements obtained in the first 2 years of fixed-dosing regimen may imply that flexible regimens and undertreatment endanger the gains obtained during bimonthly-visits phase.”
These results confirm those obtained in other extension trials, such as SEVEN-UP, CATT and VIEW 1, which showed the difficulty in maintaining results with less frequent dosing in later years. – by Michela Cimberle
Disclosure: Conti reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
Perspective
Back to Top
Paolo Lanzetta, MD
The ASSESS study reports on 18 patients who responded to previous anti-VEGF treatment and were transitioned to aflibercept bimonthly for 24 months and thereafter to anti-VEGF therapy according to best medical judgment until month 36.
The study shows that during the fixed-dosing phase, patients experienced a sustained improvement in anatomy and vision from baseline and stability when compared with baseline. Mean change in visual acuity was +7, +10 and +11 letters at 6, 12 and 24 months, respectively. During the follow-up phase from month 24 to month 36, when patients were managed according to routine clinical practice, the gain in visual acuity was +6, a nonsignificant margin with respect to baseline. The average number of treatments from baseline to month 24 was 12 whereas it reduced to 3.7 injections during year 3.
Interestingly, 12 patients followed with an as-needed modality in the third year received an average of 2.6 injections in the period and registered lower visual acuity outcomes whereas six patients followed bimonthly with fixed aflibercept had six injections with better outcomes.
Although the number of patients included is limited, this study suggests and confirms that a flexible regimen based on clinical judgment may be associated with undertreatment, and in this specific scenario, the significant gains reached during the fixed bimonthly treatment phase are lost. Once again, this highlights the importance of an adequate number of exposures to anti-VEGF in order to avoid suboptimal functional outcomes.
Click Here to Manage Email Alerts