Treat-and-Extend Regimen Is Effective in Treating Macular Disease

Researchers in Canada determined that a treat-and-extend (T&E) regimen of administering ranibizumab to patients with neovascular age-related macular disease produced comparable results to monthly dosing administrations, according to a study published in JAMA Ophthalmology.

Neovascular age-related macular degeneration is a leading cause of vision loss among elderly patients in developed nations and there is currently no cure for the disease. However, ranibizumab, an anti—vascular endothelial growth factor agent, is widely used to treat the condition.

In this randomized, open-label, multicenter, noninferiority intention-to-treat trial, 580 patients from 27 treatment centers in Canada were administered ranibizumab between May 2013 and August 2018. Patients were randomized to either a once-monthly dosing regimen or an extended schedule of intravitreal injections.

T&E regimens may vary among practitioners, but “the general approach includes a loading phase of monthly treatment followed by a maintenance phase,” researchers said. “After the loading phase, the interval between injections is progressively shortened or lengthened depending on the presence or absence of disease activity.” When T&E is successfully implemented, it can reduce the burden of monthly injections, cut down on frequent assessment-related visits, and result in better retention rates and visual outcomes.

Mean change in best-corrected visual acuity (BCVA) was measured in letters from baseline to month 24. The average age of participants was 78.8.

The study yielded the following results:

• The T&E group had a mean of 17.6 injections and visits, compared with 23.5 in the monthly group, for a difference of 5.9 injections and visits (95% CI, 5.4-6.5; P <.001)
• Mean BCVA improvement with the T&E arm was 6.8 (14.1) letters versus 6.0 (12.6) letters with the monthly arm (difference, 0.9; 95% CI, −1.6 to 3.3; P = .21)
• A gain of 15 or more letters in 25.5% of the T&E group versus 23.1% of the monthly treatment group (difference, 2.4%; 95% CI, −6.8% to 11.6%; P = .59)
• A loss of 15 or more letters in 6.5% of the T&E group and 5.8% of the monthly treatment group (difference, −0.7%; 95% CI, −9.9% to 8.5%; P = .85)
• A gain of 10 or more letters was achieved by 42.9% of the T&E group versus 36.4% of the monthly group (difference, 6.4%; 95% CI, −2.9% to 15.5%; P = .18)

Researchers concluded that the study findings confirmed the feasibility and effectiveness of T&E ranibizumab regimens and demonstrated that the T&E approach is not worse than monthly regimens.

The trial “demonstrated that a treatment tailored to patients’ individual characteristics led to clinically meaningful improvements in BCVA,” researchers said. “The T&E dosing regimen with ranibizumab attained these results with fewer injections and visits, which has the potential to increase convenience and reduce cost to the health care system compared with monthly dosing.”

Reference

Kertes PJ, Galic IJ, Greve M, et al. Efficacy of a treat-and-extend regimen with ranibizumab in patients with neovascular age-related macular disease: a randomized clinical trial [published online January 9, 2020]. JAMA Ophthalmol. doi: 10.1001/jamaophthalmol.2019.5540.