Academic Journal
Effect of Key Baseline Disease Characteristics on Aflibercept 8 mg Dosing Interval Extension
| Τίτλος: | Effect of Key Baseline Disease Characteristics on Aflibercept 8 mg Dosing Interval Extension |
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| Συγγραφείς: | Garweg J. G., Chaudhary V., Zhang X., Leal S., Machewitz T., Munk M. R., Zarranz-Ventura J., Stahl A., Lanzetta P., Schlottmann P., Zompa T., Alezzandrini A., Chang A., Arnold J., Fraser-Bell S., Luckie A., Verma N., El-Shabrawi Y., Reinelt P., Findl O., Haas A., Bolz M., Daskalov V., Mitova D., Blagoeva H., Grupcheva H., Oscar A., Petkova I., Andreev A., Vasileva P., Sheidow T., Koushan K., Gauvin L. -P., Sun X., Zhang M., Fan K., Chen X., HAN M., Dai H., Xiao J., Yang W., Liu X., Ha S., Zhang J. L., Zhou Q., Li X., He Y., Xu L., Yang L., Wu M., Tong J., Guo J., Ma L., Wang Y., Wei W., Zhao M., Pei C., Tao L., Li S., Wang L., Bi Y., Qiu X., Ren Q., Ernest J., Nemcansky J., Studnicka J., Veith M., Hamouz J., Choleva M., Fidranska H., Chrapek O., Noor K., Hannus K., Kaljurand K., Souied E., Tadayoni R., Kodjikian L., Devin F., Razavi H., Masse H., Ramazashvili M., Chichua G., Omiadze M., Jikia J., Bator G., Kerenyi A., Seres A., Papp A., Toth-Molnar E., Vajas A., Varsanyi B., Vogt G., Milibak T., Czumbel N., Moisseiev E., Platner E., Shulman S., Eting E., Hauser D., Mathalone N., Barak Y., Morori-Kats H., Jaouni T., Tognetto D., Bandello F., Ricci F., Varano M., Cagini C., Avitabile T., Peiretti E., Minnella A. M., Staurenghi G., Miki A., Oh H., Hayashi K., Fujisaki T., Yasukawa T., Sekiryu T., Ueda T., Morizane Y., Koizumi H., Yoshida S., Ohji M., Matsubara H., Iwase T., Ito Y., Takeuchi J., Takahashi K., Harada Y., Kimura K., Kataoka H., Noda T., Ono H., Takemoto D., Dannoue K., Mitamura Y., Kimoto K., Kishino G., Takahashi H., Obata R., Sakurada Y., Sakanishi Y., Murata T., Nishimura T., Yoneda A., Sasaki H., Otake H., Honda S., Mitarai K., Kusaka S., Fujita K., Ishii K., Ikeda Y., Ozawa Y., Shinoda H., Muranaka K., Ogino K., Suzuma K., Okanouchi T., Akiyama H., Kobayashi N., Iida T., Nishi K., Tanaka H., Imaizumi H., Kogo J., Yasuda K., Byon I., Yoon Y. H., Kang S. W., Lee E. K., Woo S. J., Choi M., Kim H. W., Lee W. K., Lacis I., Laganovska G., Baumane K., Balciuniene J., Cimbalas A., Kazlauskaite J., da Silva R. M., Neves C., Lume M., Silva L., Figueira J., Budzinskaya M., Malyugin B., Zolotarev A., Yurieva T., Stamenkovic M., Risimic D., Babovic S., Chee C., Cheung C. M. G., Chia K. J. W., Kacerik M., Kolar P., Lipkova B., Pavlovicova G., Hurcikova M., Sararols R. L., Jose Maria Ruiz M., Jose Ignacio Vela S., Adan C. A. M., Gonzalez A. M., Pablo J. L. E., Cervera T. E., Garcia A. J., Maria Isabel Fernandez R., Udaondo M. P., Becker M., Ambresin A., Garweg J., Pruente C., Wu W. -C., Chen S. J., Korol A., Bezkorovayna I., Shyshkina T., Povkh V., Patel J., Downes S., Younis S., Chaudhry N., Heier J., Wells J., Gonzalez V., Singer M., Ferrone P., Stoller G., Graham K., Wheatley H., Williams P., Lee M., Suan E., Liu J., Higgins P., Eichenbaum D., Ghorayeb G., Wirthlin R., Schadlu R., Thomas B., Amini P., Mein C., Garg S., Brown D., Charles S., Wykoff C., Mittra R., London N., Sheth V., Cunningham M., Farber N., Parrott M., Uchiyama E., Cherney E., Pitcher J., Abraham P., Kruger E., Palmer J., Alfaro D. V., Hubschman J. -P., Lara W., Shildkrot Y., Patel S., Tabassian A., Read S., Kim B., Weinberg A., Hershberger V., Almeida D., Dooner J., Carlson J., Mititelu M., Shah R., Freeman W., Gupta S., Pirouz A., Feldman R., McClintic S., Sampat K., Sarrafizadeh R., Nielsen J., Fox G., Golas L., Danzig C., Hahn. P. |
| Συνεισφορές: | Garweg, J. G., Chaudhary, V., Zhang, X., Leal, S., Machewitz, T., Munk, M. R., Zarranz-Ventura, J., Stahl, A., Lanzetta, P., Schlottmann, P., Zompa, T., Alezzandrini, A., Chang, A., Arnold, J., Fraser-Bell, S., Luckie, A., Verma, N., El-Shabrawi, Y., Reinelt, P., Findl, O., Haas, A., Bolz, M., Daskalov, V., Mitova, D., Blagoeva, H., Grupcheva, H., Oscar, A., Petkova, I., Andreev, A., Vasileva, P., Sheidow, T., Koushan, K., Gauvin, L. -P., Sun, X., Zhang, M., Fan, K., Chen, X., Han, M., Dai, H., Xiao, J., Yang, W., Liu, X., Ha, S., Zhang, J. L., Zhou, Q., Li, X., He, Y., Xu, L., Yang, L., Wu, M., Tong, J., Guo, J., Ma, L., Wang, Y., Wei, W., Zhao, M., Pei, C., Tao, L., Li, S., Wang, L., Bi, Y., Qiu, X., Ren, Q., Ernest, J., Nemcansky, J., Studnicka, J., Veith, M., Hamouz, J., Choleva, M., Fidranska, H., Chrapek, O., Noor, K., Hannus, K., Kaljurand, K., Souied, E., Tadayoni, R., Kodjikian, L., Devin, F., Razavi, H., Masse, H., Ramazashvili, M., Chichua, G., Omiadze, M., Jikia, J., Bator, G., Kerenyi, A., Seres, A., Papp, A., Toth-Molnar, E., Vajas, A., Varsanyi, B., Vogt, G., Milibak, T., Czumbel, N., Moisseiev, E., Platner, E., Shulman, S. |
| Έτος έκδοσης: | 2026 |
| Συλλογή: | Università degli Studi di Udine: CINECA IRIS |
| Θεματικοί όροι: | Aflibercept, Baseline characteristic, Dose regimen modification, Dosing interval, Neovascular age-related macular degeneration |
| Περιγραφή: | Objective Post hoc analysis of the PULSAR phase 3 trial (NCT04423718) to determine whether dosing interval outcomes were associated with key baseline disease characteristics. Design Exploratory post hoc analysis of PULSAR, a 96-week, double-masked, active-controlled, randomized clinical trial in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) treated with aflibercept 8 mg or aflibercept 2 mg. For the main analysis, patients receiving aflibercept 8 mg were grouped according to their last assigned dosing interval at weeks 48 and 96. Participants Patients with treatment-naïve nAMD who were randomly assigned to receive aflibercept 8 mg in PULSAR. Intervention Aflibercept 8 mg was administered every 12 weeks (8q12) or 16 weeks (8q16), each after 3 initial monthly injections. Dosing intervals could be shortened in year 1 based on prespecified disease activity criteria, whereas in year 2, both interval shortening and extension were allowed. Patients were monitored every 4 weeks but assessed for interval modification at dosing visits only. Main Outcome Measures Baseline best-corrected visual acuity (BCVA), central retinal thickness (CRT), and macular neovascularization (MNV) area were assessed in patients grouped by their last assigned dosing interval (Q8, Q12, Q16, Q20, or Q24) at weeks 48 and 96. Results In 86.6% and 78.4% of patients assigned to the 8q12 and 8q16 arms in PULSAR, respectively, randomized dosing intervals were maintained or extended through week 96. In the 8q12 arm, no trends were observed in baseline BCVA, CRT, and MNV area across groups based on patients’ last assigned dosing intervals. In the 8q16 arm, no trends were observed in baseline BCVA across treatment arms; however, patients with shorter last assigned dosing intervals (Q8 and Q12) at weeks 48 and 96 tended to have a greater baseline CRT or MNV area compared with patients with longer dosing intervals (Q16–Q24). Conclusions Overall, findings from this PULSAR post hoc analysis of key baseline characteristics ... |
| Τύπος εγγράφου: | article in journal/newspaper |
| Γλώσσα: | English |
| Relation: | journal:OPHTHALMOLOGY RETINA; https://hdl.handle.net/11390/1338564 |
| DOI: | 10.1016/j.oret.2026.06.032 |
| Διαθεσιμότητα: | https://hdl.handle.net/11390/1338564 https://doi.org/10.1016/j.oret.2026.06.032 |
| Rights: | info:eu-repo/semantics/openAccess ; license:Creative commons ; license uri:http://creativecommons.org/licenses/by/4.0/ |
| Αριθμός Καταχώρησης: | edsbas.E00450CD |
| Βάση Δεδομένων: | BASE |
| DOI: | 10.1016/j.oret.2026.06.032 |
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