Ranibizumab 0.5 mg is associated with visual acuity improvement in people with neovascular age-related macular degeneration (nAMD) regardless of the presence of polypoidal choroidal vasculopathy, according to research results published in Acta Ophthalmologica.
Researchers sought to evaluate the safety and efficacy of multiple ranibizumab 0.5 mg regimens in a cohort of patients with nAMD and polypoidal choroidal vasculopathy. A 2-year, double-masked, controlled, multicenter study was conducted in China between 2013 and 2015 (NCT01775124).
Participants were randomly assigned to receive ranibizumab 0.5 mg and follow one of 2 dosing regimens: monthly for 11 months followed by a PRN regimen, guided by visual acuity stabilization and disease activity criteria, from months 12 to 23; or via 3 consecutive monthly injections followed by a PRN regimen through month 23. The primary study outcome was the efficacy difference between monthly vs PRN regimens in stabilizing best-corrected visual acuity (BCVA) over 3 monthly assessments.
In total, 313 of 334 patients competed 12 months and 283 completed 24 months. The full analysis set included 333 patients (monthly group n=167; PRN group n=166) and the safety set included 332 patients (monthly group n=166; PRN group n=166).
Both baseline demographics and ocular characteristics were similar between the monthly and PRN treatment groups.
BCVA demonstrated a rapid increase in both treatment groups during the first 3 months of the study. At month 3, mean BCVA change from baseline was +8.0 letters in the monthly group and +7.2 letters in the PRN group. Mean average BCVA increased from month 3 to 4, and through month 12, in both groups (monthly group, 3.3 letters; PRN group, 1.7 letters). Least square mean difference in this increase was 1.6 (95% CI, -2.95 to -0.20 for both regimens). The number of patients who gained 15 letters or more in BCVA was slightly higher in the monthly group compared with the PRN group, and the number of patients with a loss of at least 15 letters or gain of 30 letters or more was comparable.
Investigators observed a decrease in mean central subfield thickness early during the treatment period — primarily during the first 2 months — in both groups, which was maintained until the end of the study. A similar trend was noted in patients with and without polypoidal choroidal vasculopathy.
In the monthly group, the mean number of ranibizumab injections between day 1 and month 11 was 11.4 vs 8.2 in the PRN group. Between months 12 and 23, the mean number of injections was similar between both groups (4.8 and 5.1 for the monthly and PRN groups, respectively).
Serious adverse events were reported by 14.5% of patients in each treatment group, with a 1.2% rate of ocular events (0.6% and 1.2% of which were treatment-related in the monthly and PRN groups, respectively). Nonocular serious adverse events were reported in 12.7% and 13.3% of patients in each group.
Limitations include a lack of generalizability to patients outside of the study population and the use of the PRN regimen in the second year in both groups, allowing for only 1 year of treatment comparison.
“The results of this study demonstrate that initial monthly doses of ranibizumab followed by a PRN regimen with regular follow-ups is an effective and viable approach for treatment of patients with nAMD and polypoidal choroidal vasculopathy,” the researchers conclude.
Disclosure: This clinical trial was supported by Novartis Pharma AG. Please see the original reference for a full list of authors’ disclosures.
Li X, Zhu Q, Egger A, et al. Two different treatment regimens of ranibizumab 0.5 mg for neovascular age-related macular degeneration with or without polypoidal choroidal vasculopathy in Chinese patients: Results from the phase IV, randomized, DRAGON study. Published online December 30, 2020. Acta Ophthalmol. doi: 10.1111/aos.14588