Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
Authors: Silva Rufino , Arias Luis , Nunes Sandrina , Farinha Claudia , Coimbra Rita , Marques João P. , Cachulo Maria L. , Figueira João , Barreto Patricia , Madeira Maria H. , Pires Isabel , Sousa João C. , Distefano Laura , Rosa Paulo , Carneiro Ângela , Vaz-Pereira Sara , Meireles Angelina , Cabrera Francisco , Bures Anniken , Mendonça Luís , Fernandez-Vega-Sanz Alvaro , Barrão Sandra , Koh Adrian , Cheung Chui Ming Gemmy , Cunha-Vaz José G. , Murta Joaquim ,   for the EVICR.net ATLANTIC Study Group
Published: July 2021

<b><i>Importance:</i></b> Polypoidal choroidal vasculopathy (PCV) is far less common and studied in a Caucasian population than in an Asian population, and the optimal treatment approach remains to be confirmed. <b><i>Methods:</i></b> A 52-week, double-masked, sham-controlled, phase 4, investigator-initiated randomized clinical trial (RCT) in naive symptomatic Caucasian patients with PCV treated with aflibercept in a treat-and-extend regimen (T&amp;E) (intravitreal aflibercept injection [IVAI] T&amp;E). Patients were randomized at week 16 to receive IVAI T&amp;E plus either sham photodynamic therapy (PDT) or standard fluence PDT with verteporfin. The main outcome measures were changes in best-corrected visual acuity (BCVA) from baseline to 52 weeks and polyp occlusion at week 52. Data are presented as median (interquartile range [IQR]) for BCVA, number of IVAI, and change in central retinal thickness (CRT). <b><i>Results:</i></b> Of the 50 patients included in the study, 48 patients completed the 52 weeks of follow-up. During this period, a significant median (IQR) BCVA gain of 6 [2–12] Early Treatment Diabetic Retinopathy Study letters was observed for all patients (<i>p</i> &#x3c; 0.001), after 8 (7–9) injections, with a significant reduction of −93.0 [−154.0, −44.0] µm in central macular thickness (<i>p</i> &#x3c; 0.001). Using indocyanine green angiography, a complete occlusion of polypoidal lesions was documented in 72% of the cases. Still, no significant difference was detected between the sham PDT and the aflibercept PDT arms, at week 52, for BCVA change (6.5 [2–11] vs. 5 [2–13] letters (<i>p</i> = 0.98)), number of IVAIs (8.5 [7–9] vs. 8 [7–9] (<i>p</i> = 0.21)), change in CRT (−143 [−184; −47] vs. −89 [−123; −41.5] µm [<i>p</i> = 0.23]), and rates of complete polyp occlusion: 77 versus 68% (<i>p</i> = 0.53) or presence of fluid: 68 versus 57% (<i>p</i> = 0.56). No serious ocular adverse events were registered in the 2 arms. <b><i>Conclusions and Relevance:</i></b> To our knowledge, this is the first RCT to compare aflibercept T&amp;E monotherapy with aflibercept T&amp;E plus verteporfin PDT in a Caucasian population with PCV. Aflibercept monotherapy in a T&amp;E showed to be effective and safe with a significant median BCVA improvement of 6 letters and a complete occlusion of polypoidal lesions in near 3 quarters of the eyes, at 1 year. As only 22% of the eyes underwent PDT treatment, the benefit of combined treatment for PCV in Caucasian patients could not be definitively elucidated from this study. <b><i>Trial Registration:</i></b> The clinical trial was registered in ClinicalTrials.gov Identifier NCT02495181 and the European Union Drug Regulating Authorities Clinical Trials Database EudraCT No. 2015-001368-20.