Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial.

PURPOSE:To evaluate efficacy and safety of intravitreal injections of aflibercept (IVT-AFL) treat-and-extend (T&E) dosing regimens in treatment-naïve patients with exudative age-related macular degeneration (AMD).METHODS:Adults aged at least 50 years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included. Patients received three monthly doses of IVT-AFL 2 mg. At week 16, patients were randomized 1:1 to IVT-AFL T&E with either 2- or 4-week adjustments. The primary endpoint was mean change in BCVA from baseline to week 52. Outcomes were assessed at weeks 52 and 96.RESULTS:Baseline characteristics were comparable between the groups (n = 123 each). Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2- and 4-week groups, respectively. From baseline, mean change in BCVA was + 9.0 and + 8.4 letters (week 52) and + 7.6 and + 6.1 letters (week 96); mean change in central retinal thickness was - 134.4 µm and - 126.1 µm (week 52) and - 130.5 µm and - 125.3 µm (week 96). Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96. Over 96 weeks, mean number of injections was 10.4 (both groups). The safety profile of IVT-AFL was consistent with previous reports.CONCLUSIONS:IVT-AFL administered using two different T&E regimens for treatment-naïve exudative AMD improved functional and anatomic outcomes at week 52 and outcomes were maintained to week 96. Outcomes were similar between the 2- and 4-week groups.TRIAL REGISTRATION:ClinicalTrials.gov identifier, NCT02305238

Resource use (hospital visits and number of injections) by treatment category in patients.

<p>Resource use (hospital visits and number of injections) by treatment category in patients.</p

Caregiving-related information obtained via self-administered questionnaires.

<p>Caregiving-related information obtained via self-administered questionnaires.</p

The impact of different anti-vascular endothelial growth factor treatment regimens on reducing burden for caregivers and patients with wet age-related macular degeneration in a single-center real-world Japanese setting

<div><p>Objective</p><p>To describe the burden associated with different anti-vascular endothelial growth factor (VEGF) treatment strategies for wet age-related macular degeneration (wAMD) in a real-word setting in Japan.</p><p>Methods</p><p>Single-center, cross-sectional survey of caregivers of patients with wAMD performed in a hospital in Mito-City, a rural area in Japan. Caregiver burden was evaluated using the Burden Index of Caregivers (BIC-11), and depressive symptoms were assessed by the Center for Epidemiologic Studies Depression scale. Retrospective medical chart review was conducted to monitor resource use and visual acuity outcomes in patients. The productivity loss of caregivers accompanying patients on hospital visits was estimated using the human capital method.</p><p>Results</p><p>Seventy-one patient-caregiver pairs were included. Most caregivers were female (74.6%), spouse/partner (54.9%), employed (46.5%), and the primary caregiver (85.9%). Patients received anti-VEGF treatment as follows: treat-and-extend (T&E; n = 42), switch (from as-needed [PRN] to T&E; n = 18), PRN (n = 10), and other (n = 1). Caregiver-related burden (total BIC-11 scores) were 4.29 (T&E) 4.60 (PRN), and 5.33 (switch) (p = NS).</p><p>The mean number of hospital visits was lower with T&E than PRN (7.88 vs. 14.0 [p = 0.00674] in year 1 and 5.68 vs. 9.0 in year 2). For patients who switched from PRN to T&E, the mean number of hospital visits decreased from 13.21 to 7.43 (p<0.0001) in the first year after switch. The productivity loss associated with accompanying patients to the hospital was lower for caregivers of patients receiving T&E than PRN (mean differences: 74,456.04 JPY [p = 0.00284] in year 1 and 40843.14 JPY in year 2), and was also reduced for caregivers of patients who switched from PRN to T&E.</p><p>Conclusion</p><p>wAMD treatment with anti-VEGF agents via T&E reduced hospital visits compared with PRN, where associated monitoring visits are necessary to provide good patient outcomes. T&E was associated with a reduction trend in caregiver burden, including time and costs.</p></div

Mean change in BCVA (ETDRS letters) score over 2 years by treatment category (better-seeing eye).

<p>BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; LOCF; last observation carried forward; PRN, as-needed; T&E, treat-and-extend. For time points 6, 12, 18, 24, and 24 (LOCF) months, respectively, n = 18, 16, 15, 16, and 18 (PRN to T&E switchers), n = 38, 33, 27, 22, and 39 (T&E), and n = 10, 10, 10, 9, and 10 (PRN). *p<0.05 versus baseline (paired <i>t</i> test).</p

Estimated annual costs for accompanying patients on hospital visits, and total annual caregiving cost by visual impairment category (better-seeing eye).

<p>Estimated annual costs for accompanying patients on hospital visits, and total annual caregiving cost by visual impairment category (better-seeing eye).</p

Disposition of participants.

<p>PRN, as-needed; T&E, treat-and-extend.</p

Caregiving-related information obtained via self-administered questionnaires.

<p>Caregiving-related information obtained via self-administered questionnaires.</p

Total and domain BIC-11 scores for caregivers by patient treatment and visual impairment (better-seeing eye) categories.

<p>Total and domain BIC-11 scores for caregivers by patient treatment and visual impairment (better-seeing eye) categories.</p