title: Aflibercept as a Second Line Therapy for Neovascular Age Related Macular Degeneration in Israel (ASLI) study.
abstract: PurposeThe purpose of this study is to evaluate an early switch to aflibecept in eyes with neovascular age-related macular degeneration (nvAMD) showing partial or lack of response for initial therapy with bevacizumab.MethodsThe Aflibercept as a Second Line Therapy for Neovascular Age Related Macular Degeneration in Israel (ASLI) was a prospective, multicenter, single-arm clinical trial. Eyes with nvAMD having incomplete response to 3-9 prior bevacizumab injections were recruited. Three monthly intravitreal aflibercept (2 mg) injections were administered, followed by two bi-monthly injections and a final examination at week 28. An optional injection was allowed at week 20.ResultsForty-seven eyes of 46 patients (mean±SD age 76±8 years) were recruited. The mean number of prior bevacizumab injections was 5.5±2.9. The mean visual acuity improved from 60.3±10 ETDRS letters at baseline to 63.1±15 letters at week 28 (P=0.02, paired t-test). The central subfield thickness (CST) reduced from 409±127 micron at baseline to 330±110 microns at week 4 (P=0.0002; paired t-test), and 277±70 microns at week 28 (P=0.00002; paired t-test). Twenty-two eyes had three to five prior bevacizumab injections (mean 5.1±0.7), and 25 eyes had six to nine prior injections (7.32±1.2). Both groups had reduced CST from baseline to week 28 (P=0.0004 and P=0.0007; paired t-test, respectively). Thirty-five (75%) eyes required the optional additional aflibercept injection at week 20.ConclusionsThe ASLI study demonstrated improved BCVA and reduced CST following an early switch to aflibercept therapy in eyes with prior incomplete response to initial therapy with three to nine bevacizumab injections.
authors.affiliation: Department of Ophthalmology Hadassah, Hebrew University Medical Center, Jerusalem, Israel.
authors.forename: L
authors.initials: L
authors.lastname: Tiosano
authors.affiliation: Meir Medical Center, Kfar Sava, affiliated to the Sackler School of Medicine, Tel Aviv University, Israel.
authors.forename: O
authors.initials: O
authors.lastname: Segal
authors.affiliation: Carmel Medical Center, Haifa, Israel.
authors.forename: N
authors.initials: N
authors.lastname: Mathalone
authors.affiliation: Kaplan Medical Center, Rehovot, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Pollack
authors.affiliation: Rabin Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Israel.
authors.forename: R
authors.initials: R
authors.lastname: Ehrlich
authors.affiliation: Soroka University Medical Center, Beer Sheva, Israel.
authors.forename: I
authors.initials: I
authors.lastname: Klemperer
authors.affiliation: Rambam Medical Center, Haifa, Israel.
authors.forename: Y
authors.initials: Y
authors.lastname: Barak
authors.affiliation: Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: I
authors.initials: I
authors.lastname: Moroz
authors.affiliation: Department of Ophthalmology Hadassah, Hebrew University Medical Center, Jerusalem, Israel.
authors.forename: I
authors.initials: I
authors.lastname: Chowers
authors.affiliation: Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Israel.
authors.forename: M
authors.initials: M
authors.lastname: Goldstein
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D000068258:Bevacizumab / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D057915:Drug Substitution; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D007557:Israel / Q000453:epidemiology; D008266:Macula Lutea / Q000473:pathology; D008297:Male; D015995:Prevalence; D011446:Prospective Studies; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage* / Q000037:antagonists & inhibitors; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity; D057135:Wet Macular Degeneration / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C533178:aflibercept; D000068258:Bevacizumab; D040262:Receptors, Vascular Endothelial Growth Factor