Author: Prem Nichani (Canada)
Co-authors: Marko M. Popovic, Arjan S. Dhoot, Ananya Pathak, Rajeev H. Muni, Peter J. Kertes
Purpose
Intravitreal injections (IVI) of antiangiogenic agents are pivotal in treating neovascular age-related macular degeneration (nAMD). Treat-and-extend (T&E) dosing aims to maintain and maximize visual gains while reducing the burden of ongoing injections. This meta-analysis aims to elucidate the comparative efficacy and safety of anti-vascular endothelial growth factor (VEGF) IVIs via T&E versus bimonthly, monthly, and pro re nata (PRN) dosing regimens.
Setting/Venue
Systematic review and meta-analysis.
Methods
We conducted a systematic literature search of Ovid MEDLINE, EMBASE, and Cochrane CENTRAL to September 2020. English-language RCTs reporting on efficacy and/or safety outcomes of T&E in comparison to bimonthly, monthly, and/or PRN dosing regimens of anti-VEGF IVIs in nAMD patients were included. Critical appraisal was performed using Cochrane bias assessment and GRADE guidelines. The primary outcome was improvement in best corrected visual acuity (BCVA); secondary outcomes included changes in central subfield thickness (CSFT), mean number of injections administered, and incidence of adverse events. All outcomes were collected at last follow-up. Meta-analyses were conducted using a random effects model; weighted mean differences (WMD) and risk ratios (RR) were calculated.
Results
Across six included RCTs, 781 eyes were treated with a T&E IVI dosing regimen, 663 received monthly, 130 PRN, and 123 bimonthly IVIs. There was a low risk of bias across the trials. Mean changes in BCVA and CSFT at last follow-up were similar between T&E versus monthly (WMD, –0.62; 95%CI, –2.12 to 0.87; P=0.41; and WMD, 5.30; 95%CI, –10.67 to 21.26; P=0.52, respectively), bimonthly (WMD, 0.30; 95%CI, –3.49 to 4.09; P=0.88; and WMD, –18.91; 95%CI, –46.41 to 8.60; P=0.18, respectively), and PRN (BCVA WMD, 0.05; 95%CI, –3.55 to 3.66; P=0.98) dosing regimens. T&E was associated with a significantly reduced injection burden versus monthly (WMD, –4.52; 95%CI, –6.66 to 2.39; P<0.001) but higher injection burden versus PRN (WMD, 1.81; 95%CI, 1.12 to 2.51; P<0.001) dosing at final follow-up. There was no significant difference in safety outcomes amongst comparators.
Conlusions
The efficacy and safety outcomes of T&E, bimonthly, monthly, and PRN dosing were non-significantly different. However, T&E eyes had significantly fewer injections and clinic visits compared to monthly and PRN, respectively. Future assessment of patient satisfaction, treatment adherence, and cost savings with T&E regimens is recommended.
Financial Disclosure
Conflicts of Interest: PN: None. MMP: PSI Foundation (RI). ASD: None. AP: None. RHM: Allergan (C), Bayer (C, RI), Novartis (C, RI), Roche (C). PJK: Alcon (C), Allergan (RI), ArcticDx (E), Bayer (C, RI, RP), Novartis (C, RI, RP), Novelty Nobility (C), Roche (RI). Legend: C – consultant/consulting fees; E – equity owner; S – speaker honoraria; RI – research grant/financial support (to institution); RP – research grant/financial support (personal)
Comments
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