PURPOSE:The ANDROMEDA (intravitreal Aflibercept in Neovascular amD: an obseRvational study assessing patient relevant OutcoMes, rEal-worlD treatment pattern And effectiveness) study was planned to assess adherence to intravitreal aflibercept (IVT-AFL) 2 mg treatment over 24 months for neovascular age-related macular degeneration (nAMD) and to identify patient- and physician-related factors for nonadherence (NA) in clinical settings.
DESIGN:Prospective, observational, noncontrolled, multicenter cohort study.
SUBJECTS:Treatment-naïve and previously treated adult patients with nAMD under IVT-AFL treatment from 41 centers in Germany.
METHODS:Time to first occurrence of NA was analyzed descriptively using Kaplan-Meier methods followed by a Cox model to explore the potential impact of patient- and physician-related factors on NA. Participants reported reasons for NA in standardized telephone interviews.
MAIN OUTCOME MEASURES:Primary endpoints were time to first occurrence of and reasons for NA. Secondary endpoints included change in best-corrected visual acuity and central retinal thickness from baseline to months 4, 12, and 24.
RESULTS:The median time to first NA was 180 days in the 509 study participants (mean age: 77.2 years; 57.2% female). Among them, 44.0% were treatment-naïve, 22.6% were previously treated with IVT-AFL, and 33.4% were previously treated with other anti-VEGF agents (VEGF). Adherence rates, particularly among treatment-naïve participants, fell early and markedly: 69.6% at 4 months (95% confidence interval [CI]: 62.9%-75.3%), 53.0% at 12 months (95% CI: 46.0%-59.5%), and 40.1% at 24 months (95% CI: 33.3%-46.9%). Key risk factors for NA (hazard ratio [HR] <1 indicating a higher risk of NA for the mentioned factor, HR > 1 indicating a lower risk for the mentioned factor) included presence of any "other diseases" in the treatment-naïve cohort at baseline (HR: 0.57; 95% CI: 0.37-0.88), and patient-reported "lack of information for accompanying persons" (HR: 1.36; 95% CI: 1.03-1.79), involvement of referrals and multiple providers (HR: 0.76; 95% CI: 0.60-0.97), and "bilateral AMD" (HR: 0.73; 95% CI: 0.57-0.93) in the total cohort.
CONCLUSIONS:In the ANDROMEDA study, key determinants of NA were comorbidities, bilateral disease, treatment by multiple providers, and a lack of patient caregiver education. Thus, better adherence may be achieved through holistic patient management, considering additional disease parameters, single-center treatment, and improved (caregiver) education.
FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.