Effect of 2-Year HARBOR Results of Individualized Dosing in Patients With Wet Age-Related Macular Degeneration
Narrative Responses:
Purpose
To evaluate if as-needed (PRN) treatment with ranibizumab can maintain vision gained in year 1 of HARBOR, and provide similar visual acuity gains as monthly dosing over 2 years, with comparable safety, in treatment-naïve patients with subfoveal neovascular age-related macular degeneration (wet AMD).
Methods
In the 24-month, phase III HARBOR study, patients aged ≥50 years (n=1097) were randomized 1:1:1:1 to receive ranibizumab 0.5-mg or 2.0-mg monthly or PRN after 3 monthly loading doses. The primary endpoint was the mean change from baseline in best-corrected visual acuity (BCVA) at Month (M) 12. Key secondary endpoints in year 2 included mean change from baseline in BCVA at M24, the proportion of patients who gained ≥15 letters in BCVA, and the mean number of ranibizumab injections. Ocular and systemic safety events were also evaluated through M24.
Results
The mean change from baseline in BCVA at M24 was (letters): +9.1 (0.5-mg monthly), +7.9 (0.5-mg PRN), +8.0 (2.0-mg monthly), and +7.6 (2.0-mg PRN), representing a change from M12 of -1.0, -0.3, -1.2, and -1.0 letters, respectively. For 0.5-mg PRN patients who completed M24, the total injections per patient ranged from 3-24 over 2 years; the average treatment interval was 9.9 weeks after 3 monthly loading doses and 93% of patients did not require monthly dosing. Ocular and systemic safety profiles over 2 years were similar between all 4 treatment groups, and were consistent with previous ranibizumab trials in AMD.
Conclusion
Similar to M12, clinically meaningful BCVA improvements were observed at M24 in all 4 treatment groups. The majority of PRN patients did not require monthly dosing over 2 years, indicating that an individualized treatment approach with ranibizumab 0.5-mg may be appropriate for most patients with wet AMD.