This prospective, open-label, single-arm, non-randomized clinical trial, assessed the efficacy of a 2-year treat-and-extend (T&E) regimen involving intravitreal aflibercept injection (IAI), with the longest treatment interval set to 16 weeks, and adjunct focal/grid laser in diabetic macula edema (DME) patients. We examined 40 eyes (40 adults) with fovea-involving DME from 8 Japanese centers between April 2015 and February 2017. Participants received IAI with an induction period featuring monthly injections and a subsequent T&E period featuring 8-16-week injection interval, adjusted based on optical coherence tomography findings. The primary endpoints were mean changes in the best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Thirty patients (75%) completed the 2-year follow-up. The mean BCVA and CST changed from 60.5 ± 15.6 letters and 499.2 ± 105.6 µm at baseline to 66.6 ± 17.1 letters (P = 0.217) and 315.2 ± 79.0 µm (P < 0.001), respectively, after 2 years. The treatment interval was extended to 12 and 16 weeks in 6.7% and 66.7% of patients, respectively, at the end of 2 years. The T&E aflibercept regimen with the longest treatment interval set to 16 weeks, with adjunct focal/grid laser may be a rational 2-year treatment strategy for DME.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7904904PMC
http://dx.doi.org/10.1038/s41598-021-83811-yDOI Listing

Publication Analysis

Top Keywords

2-year treat-and-extend
8
period featuring
8
outcomes 2-year
4
treat-and-extend regimen
4
regimen aflibercept
4
aflibercept diabetic
4
diabetic macular
4
macular edema
4
edema prospective
4
prospective open-label
4

Similar Publications

Article Synopsis
  • - The SWAN trial aims to evaluate the effectiveness and safety of faricimab for treating diabetic macular edema (DME) by using a flexible "treat-and-extend" dosing strategy adapted to each patient's needs.
  • - Participants will receive three initial injections of faricimab every four weeks, and then their dosing schedule will be adjusted based on their DME status, either extending or shortening the intervals.
  • - The study will measure changes in visual acuity and other vision-related metrics over two years, with an emphasis on determining appropriate individualized treatment plans for better patient outcomes.
View Article and Find Full Text PDF

Purpose: To evaluate 2-year outcomes of intravitreal aflibercept injection for neovascular age-related macular degeneration (nAMD) treated with "observe before treat-and-extend (O-TAE)" strategy in the real-world setting.

Methods: This retrospective study included treatment-naive nAMD patients treated with aflibercept using O-TAE regimen and followed up for more than 2 years. Patients were observed bimonthly to check recurrence after three monthly loading injections.

View Article and Find Full Text PDF

Purpose: To evaluate the 2-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema (DME) in the YOSEMITE Japan subgroup.

Study Design: YOSEMITE/RHINE (NCT03622580/NCT03622593) subgroup analysis: global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 faricimab trials.

Methods: Patients were randomized 1:1:1 to intravitreal faricimab 6.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!