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Louis Chang, Rahul N. Khurana, Bann-mo Day, Avanti Ghanekar, Ivaylo Stoilov; Association Between Timing of Peak Vision Gain and Long-Term Outcomes of Ranibizumab for nAMD: A Post Hoc Analysis of HARBOR. Invest. Ophthalmol. Vis. Sci. 2018;59(9):836.
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This post-hoc analysis of HARBOR (NCT00891735) identified the time of peak vision gain of patients treated with ranibizumab (RBZ), either as needed (PRN) or monthly, for neovascular age-related macular degeneration (nAMD). Magnitude of peak vision gain and 24-month (M) visual outcomes of early and late “peakers” were compared.
This retrospective analysis examined best-corrected visual acuity (BCVA) outcomes in 943 patients with nAMD from HARBOR, given RBZ monthly or PRN (0.5/2.0 mg pooled) following 3 consecutive monthly doses. Patients were grouped by time of greatest overall vision gain (peak) from baseline (BL): day (D)7–M6, M7–M12, M13–M18, and M19–M24. End points included the net gain in vision from BL to peak, and from BL to end of study (M24).
Surprisingly, most patients (63.5% of PRN [n=474]; 69.7% of monthly [n=469]) reached peak vision after 6M of treatment. From BL to peak vision, patients in the PRN arm (n=474) gained a mean 12.4–22.6 ETDRS letters, with “late peakers” (ie peak achieved after M6) associated with a greater magnitude of peak vision. The mean BCVA changes from BL at M24 were –1.6, 8.5, 14.8, and 17.7 letters in D7–M6 (n=173), M7–M12 (n=100), M13–M18 (n=95), and M19–M24 (n=106) groups, respectively. This reflects a nearly 4-line difference among groups at M24, trending toward higher gains for late peakers. Importantly, similar results were observed in the monthly arm, suggesting a disease effect rather than a treatment effect. Patients achieved mean BCVA gains from BL to peak of 13.0–23.0 letters. Mean BCVA changes from BL at M24 were –1.9, 10.1, 13.5, and 18.7 letters in D7–M6 (n=142), M7–M12 (n=104), M13–M18 (n=104), and M19–M24 (n=119) groups, respectively. BL characteristics were similar among patients in all subgroups (PRN and monthly), suggesting that “peak vision” is not associated with BL characteristics.
The current nAMD treatment paradigm assumes it takes 3–6 injections to evaluate response to anti-VEGF treatment. Most patients in HARBOR reached peak vision after >6M of treatment, regardless of PRN or monthly dosing. The magnitude of vision gains was smaller for early vs late peakers. At M24, there was a nearly 4-line difference between the early (D7–M6) and late (M19–M24) gainers. These results suggest that vision recovery may take longer, and consistent treatment may be of long-term benefit.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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