Treat-and-Extend for Wet AMD Garners More Support
Ophthalmology, January 2018
Monthly injections of ranibizumab can improve best-corrected visual acuity (BCVA) outcomes in patients with neovascular age-related macular degeneration (AMD), but the frequency of dosing can be inconvenient. Silva et al. compared monthly and treat-and-extend (T&E) protocols in patients with wet AMD and concluded that T&E was statistically noninferior and clinically comparable to monthly treatment for improving visual acuity.
This 12-month phase 3 trial was conducted at 90 centers in 18 countries. The main objective was to demonstrate noninferiority of ranibizumab T&E, as measured by change in BCVA from baseline to study endpoint.
Secondary outcome measures were safety, treatment exposure, and changes in retinal central subfield thickness (CSFT).
Patients ≥ 50 years of age (mean age, 75.2 years; 55.4% women; 91.8% white) with newly diagnosed wet AMD were assigned randomly to receive ranibizumab 0.5 mg either according to a T&E regimen (n = 323) or monthly (n = 327). Demographics and baseline ocular characteristics were similar for the study groups.
Approximately 90% of each group completed the study. At 12 months, the least-squares mean BCVA change from baseline reflected improvement of 6.2 letters with T&E and 8.1 letters with the monthly regimen (p < .001 for noninferiority). Both groups had rapid gains in BCVA, primarily during the first 6 months, which continued throughout the study. Mean changes in CSFT were similar: 169.2 μm in the T&E group and 173.3 μm in the monthly group.
The mean number of ranibizumab injections was lower in the T&E group (8.7, vs. 11.1 for those treated monthly), as was the mean number of postbaseline visits (8.9 and 11.2, respectively). Types and rates of adverse events were similar.
The authors concluded that the T&E approach is not inferior to the monthly regimen. Advantages of T&E include treatment individualization, fewer injections, less-frequent visits, and lower costs.
The original article can be found here.