Treat-and-Extend Ranibizumab Regimen for AMD Comparable to Monthly Regimens

Rufino Silvia, MD, PhD

An international study led by Rufino Silvia, MD, PhD, with the Department of Ophthalmology at Centro Hospitalar e Universitário de Coimbra (CHUC) in Portugal, found that a treat-and-extend (TE) regimen of ranibizumab (Lucentis, Genentech/Roche) is statistically non-inferior and clinically comparable to a monthly regimen of ranibizumab in terms of improving visual acuity (VA) in neovascular age-related macular degeneration (AMD).

The TREND study, investigating the efficacy and safety of monthly ranibizumab 0.5 mg TE regimens, was designed as a 12-month, multicenter, randomized, intervention study to compare the effects of TE versus monthly ranibizumab regimens on best-corrected VA (BCVA) in patients.

The study, which included 650 treatment-naive AMD patients aged 50 and older (mean age, 75.2 years), determined that not only were the 2 treatment regimens comparable in their effects on VA in patients, the TE regimen resulted fewer injections (8.7 vs. 11.1) for patients, which may lift the burden of treatment for patients while reducing medical costs.

According to Silvia and colleagues, the TREND study population included “treatment-naïve patients 50 years of age or older with visual impairment resulting from active CNV secondary to AMD confirmed by the presence of active leakage of CNV detected by fluorescein angiography, color fundus photography, or both.”

The study inclusion criteria included factors related to fibrosis (less than 50% of lesion areas) and BCVA scores between 23 and 78 on the Early Treatment Diabetic Retinopathy Study (EDTRS). Enrolled patients were randomized 1:1 for standardized monthly treatments of ranibizumab 0.5 mg or TE treatments based on VA assessment and use of spectral-domain optical coherence tomography (OCT) as guiding therapy for treatment.

Silvia reported that 89.8%% of the patients receiving TE (n = 393) and 90.2% of the patients receiving monthly (n = 326) regimens completed the study, and only 11 patients reported adverse events (AEs) associated with treatment. “Demographic and baseline ocular characteristics were well balanced between the 2 treatment groups,” Silvia reported.

Baseline BCVA was an average of 60 letters for both groups at the start, and improved by 6.2 letters in the TE group and by 8.1 letters in the monthly group for a mean difference of 1.9 letters between the treatment groups (95% CI, —3.83 to 0.07; P <.001). Sylva wrote that “patients in both treatment groups achieved a rapid gain in BCVA during the study; most of the improvement occurred during the first 6 months and was maintained until the end of the study.”

Both groups of patients also saw similar changes in central subfield foveal thickness (CSFT) from baseline to the end of the study. Patients on the TE regimen saw an average —169.2 μm (n = 291) change in CSFT while patients on the monthly regimen saw a –173.3 μm (n = 297) change in CSFT.

Silvia reports that the mean change in choroidal neovascularization (CNV) leakage area from baseline during the study was —1.964 mm² in TE patients versus —2.266 mm² in monthly regimen patients. The similarities in treatment outcomes and safety were evident between the 2 groups, but there were definite differences between the mean number of ranibizumab injections received by each group.

Overall, the data showed that patients in the TE group received fewer injections in comparison to the monthly group. During the 12-month study, TE patients received a mean 8.7 injections (SD, 2.68) in comparison to the monthly regimen patients who received 11.1 (SD, 2.43) injections. Silvia noted that “a large proportion of patients (61.9%) treated with the TE regimen had a maximum treatment interval of 8 weeks or more” between injections.

The data from the TREND study, Silvia writes, supports data from previous studies which suggests “that a large proportion of patients with AMD maintain VA gains with individualized PRN [pro re nata/as needed] treatments.”

TE treatments, Silvia stated, consider “varying patient requirements, thus allowing for a tailored follow-up schedule.” Silvia and colleagues suggested that the TE approach to ranibizumab therapy “offers opportunities to individualize patient management while minimizing treatment burden and costs associated with patient care.”

The article "Treat-and-Extend versus Monthly Regimen in Neovascular Age-Related Macular Degeneration" appears in American Academy of Ophthalmology.

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