Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
Year: 2021
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: IMPORTANCE: 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. METHODS: 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&E) (intravitreal aflibercept injection [IVAI] T&E). Patients were randomized at week 16 to receive IVAI T&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). RESULTS: 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 (p < 0.001), after 8 (7-9) injections, with a significant reduction of -93.0 [-154.0, -44.0] µm in central macular thickness (p < 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 (p = 0.98)), number of IVAIs (8.5 [7-9] vs. 8 [7-9] (p = 0.21)), change in CRT (-143 [-184; -47] vs. -89 [-123; -41.5] µm [p = 0.23]), and rates of complete polyp occlusion: 77 versus 68% (p = 0.53) or presence of fluid: 68 versus 57% (p = 0.56). No serious ocular adverse events were registered in the 2 arms. CONCLUSIONS AND RELEVANCE: To our knowledge, this is the first RCT to compare aflibercept T&E monotherapy with aflibercept T&E plus verteporfin PDT in a Caucasian population with PCV. Aflibercept monotherapy in a T&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. TRIAL REGISTRATION: 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.
Source: Ophthalmologica
DOI: 10.1159/000518235
Authors: Rufino Silva, Luis Arias, Sandrina Nunes, Claudia Farinha, Rita Coimbra, João P. Marques, Maria L. Cachulo, João Figueira, Patricia Barreto, Maria H. Madeira, Isabel Pires, João C. Sousa, Laura Distefano, Paulo Rosa, Ângela Carneiro, Sara Vaz-Pereira, Angelina Meireles, Francisco Cabrera, Anniken Bures, Luís Mendonça, Alvaro Fernandez-Vega-Sanz, Sandra Barrão, Adrian Koh, Chui Ming Gemmy Cheung, José G. Cunha-Vaz, Joaquim Murta, for the EVICR.net ATLANTIC Study Group
Institutions: Unidade Local de Saúde de Coimbra, Association for Innovation and Biomedical Research on Light and Image, University of Coimbra, Bellvitge University Hospital, Universidade Técnica do Porto, Centro Hospitalar Leiria EPE, Vall d'Hebron Hospital Universitari, Hospital de São João, University of Lisbon, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria, Hospital de Santo António, Centro Hospitalar do Porto, Hospital Universitario Insular de Gran Canaria, Instituto de Microcirugía Ocular, Hospital de São Marcos, Hospital Braga, Fernández-Vega Ophthalmological Institute, Instituto de Oftalmologia Dr Gama Pinto, Eye & Retina Surgeons, Singapore Eye Research Institute
Language: English
Subfield: Ophthalmology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W3190386149