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  • Rinucumab Plus Aflibercept Versus Aflibercept Alone for Wet AMD

    By Lynda Seminara
    Selected By: Stephen D. McLeod, MD
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    Journal Highlights

    Ophthalmology, February 2020

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    Heier et al. compared the efficacy and safety of aflibercept plus rinucumab to that of aflibercept monotherapy in patients with neovascular age-related macular degeneration (AMD). They found that the combination treatment did not significantly improve best-cor­rected visual acuity (BCVA).

    This phase 2 multidose study includ­ed 505 patients (≥50 years of age) whose BCVA ranged from 73 to 24 letters. Participants were randomly allocated to receive intravitreal low-dose (1 mg) rinucumab + aflibercept 2 mg, high-dose (3 mg) rinucumab + aflibercept 2 mg, or aflibercept 2 mg monotherapy. These treatments were given every four weeks through week 12. Following this, patients on the low-dose combination continued the same treatment through week 28. Patients in the other groups were randomly assigned to continue their treatment or switch to the other treatment. Follow-up occurred every four weeks through week 52.

    At week 12, mean BCVA gains were 5.8 letters with both combinations of aflibercept/rinucumab and 7.5 letters with aflibercept alone. By 12 weeks of treatment, 12%, 19%, and 22% of eyes on the low-dose combo, high-dose combo, and aflibercept monotherapy (respectively) had gained at least 15 letters. The mean reductions in central retinal thickness from baseline were 126.1, 127.1, and 126.9 μm, respectively. The proportions of eyes with complete fluid resolution were 35%, 24%, and 42%, respectively. Vision and anatomic outcomes at week 28 were consistent with week 12 results. Through week 52, intraocular inflammation was infre­quent except in the high-dose combi­nation group (incidence of 7.5%). The most common ocular adverse events were conjunctival hemorrhage and retinal hemorrhage. By 52 weeks, more than a third of the study population had experienced at least one ocular adverse event.

    This research suggests that adding rinucumab to aflibercept does not produce better visual or anatomic outcomes than aflibercept alone in treatment-naive patients with neovas­cular AMD.

    The original article can be found here.