Abstract
Purpose :
Many patients with nAMD achieve clinically relevant vision gains or stability with less-than-monthly anti-VEGF dosing. This study investigates this subset of patients across 7 clinical trials to determine the visual gains of these patients treated with quarterly anti-VEGF dosing.
Methods :
This cross-trial investigation assessed patients from CABERNET (NCT01016873), EXCITE (NCT00275821), VIEW (NCT00509795/NCT00637377), PIER (NCT00090623), HAWK (NCT02307682), and HARRIER (NCT02434328) to determine the visual gains of patients on a 12-week anti-VEGF dosing interval for the treatment of nAMD, following 3 consecutive monthly loading doses. Additional analyses will identify predictors of response to q12 week dosing.
Results :
In CABERNET, the control group (n=163) received 0.5 mg ranibizumab (RBZ) quarterly after 3 consecutive monthly loading doses. At M12, 71% of these patients required no interventional therapy, gaining a mean 8.2 ETDRS letters from baseline (BL). At month (M)12 of EXCITE, patients in the RBZ 0.3 mg (n=120) and 0.5 mg (n=118) quarterly groups (intent-to-treat) gained from BL a mean 4.0 and 2.8 ETDRS letters, respectively. Approximately 41.6% of patients receiving quarterly RBZ maintained initial BCVA gains during EXCITE. During weeks 52–96 of the VIEW trials, some patients achieved a ≥12 week dosing interval from the 0.5 mg RBZ q4 weeks (n=218; 43%), 2 mg aflibercept (AFL) q4 week (n=284; 54%), and q8 week (n=245; 48%) groups. At week 96, these patients gained a mean 9.2 (AFL2q8), 8.8 (AFL2q4), and 8.5 (RBZq4) ETDRS letters from BL. In PIER, patients received 3 consecutive monthly doses of 0.3 mg (n=60) or 0.5 mg RBZ (n=61) then quarterly dosing through M12. Patients maintained vision, with mean changes from BL of –1.6 and –0.2 ETDRS letters in the 0.3 mg and 0.5 mg RBZ groups at M12, respectively. 54% of patients maintained their initial visual acuity gains at M12. In HAWK and HARRIER, 57 and 52% of patients receiving brolucizumab 6 mg maintained vision over 48 weeks in the 12-week dosing groups.
Conclusions :
These studies suggest that ~50% of patients with nAMD respond well to a 12-week dosing interval when treated with anti-VEGF monotherapy of RBZ, AFL, or brolucizumab. Additional analyses will investigate predictors of response of these patients to identify others who respond well to a 12-week dosing interval, minimizing patient and physician burden.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.