A single-arm, investigator-initiated study of the efficacy, safety and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration, previously treated with ranibizumab or bevacizumab: 6-month interim analysis

Abstract

Aim: To evaluate efficacy and safety of intravitreal aflibercept injection (IAI) in subjects who were previously treated with ranibizumab and/or bevacizumab for active exudative age-related macular degeneration (AMD).

Methods: Patients (n=26) were enrolled in a 12-month prospective, interventional, single arm, investigator-initiated study with planned 6-month interim analysis. Patients with active exudative AMD, previously treated with ranibizumab and/or bevacizumab, were treated with 2 mg IAI every month for the first 3 months, followed by a fixed dosing schedule of 2 mg IAI every 2 months. The primary study endpoint was the mean absolute change from baseline central subfield thickness (CST) at month 12 as measured by SDOCT. Secondary outcomes included mean change from baseline best-corrected visual acuity (BCVA) score, percentage of subjects who gained or lost greater than or equal to 15 letters of vision, percentage of subjects who are 20/40 or better, percentage of subjects who are 20/200 or worse, and the incidence of adverse events (AE) and serious AEs.

Results: Planned 6-month interim analysis demonstrated a mean decrease in CST of 38.6 µm (p<0.001) and a mean increase in ETDRS BCVA of +5.9 letters (p<0.001). Fifteen percent of subjects experienced a greater than 15-letter improvement in visual acuity, 84.6% of patients gained visual acuity, and no patient lost 3 lines of vision from baseline. Forty-two percent of subjects were 20/40 or better, and 11.5% of subjects were 20/200 or worse at month 6. No serious ocular or systemic AEs were encountered.

Conclusions: IAI-treated eyes demonstrated improved short-term functional and anatomic endpoints in subjects with active exudative AMD switching from previous anti-VEGF treatment when given in a fixed dosing scheme for 6 months.

Trial registration number: NCT01617148.

Keywords: Angiogenesis; Clinical Trial; Macula; Neovascularisation; Retina.

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Figures

Figure 1

ASSESS study design.

Figure 2

Mean change from baseline in best-corrected visual acuity (BCVA) score.

Figure 3

Mean change from baseline in central subfield thickness.

Figure 4

Best-corrected visual acuity distribution at month 6.

Figure 5

Optical coherence tomography fluid status in patients at month 6.

Figure 6

Representative patient from the ASSESS trial demonstrating treatment response.