To test the hypothesis that tolerating some subretinal fluid (SRF) in patients with neovascular agerelated macular degeneration (nAMD) treated with ranibizumab using a treat-and-extend (T&E) regimen can achieve similar visual acuity (VA) outcomes as treatment aimed at resolving all SRF.Design: Multicenter, randomized, 24-month, phase 4, single-masked, noninferiority clinical trial.Participants: Participants with treatment-naïve active subfoveal choroidal neovascularization (CNV). Methods: Participants were randomized to receive ranibizumab 0.5 mg monthly until either complete resolution of SRF and intraretinal fluid (IRF; intensive arm: SRF intolerant) or resolution of all IRF only (relaxed arm: SRF tolerant except for SRF >200 mm at the foveal center) before extending treatment intervals. A 5-letter noninferiority margin was applied to the primary outcome.Main Outcome Measures: Mean change in best-corrected VA (BCVA), and central subfield thickness and number of injections from baseline to month 24.Results: Of the 349 participants randomized (intensive arm, n ¼ 174; relaxed arm, n ¼ 175), 279 (79.9%) completed the month 24. The mean change in BCVA from baseline to month 24 was 3.0 letters (standard deviation, 16.3 letters) in the intensive group and 2.6 letters (standard deviation, 16.3 letters) in the relaxed group, demonstrating noninferiority of the relaxed compared with the intensive treatment (P ¼ 0.99). Similar proportions of both groups achieved 20/40 or better VA (53.5% and 56.6%, respectively; P ¼ 0.92) and 20/200 or worse VA (8.7% and 8.1%, respectively; P ¼ 0.52). Participants in the relaxed group received fewer ranibizumab injections over 24 months (mean, 15.8 [standard deviation, 5.9]) than those in the intensive group (mean, 17 [standard deviation, 6.5]; P ¼ 0.001). Significantly more participants in the intensive group never extended beyond 4-week treatment intervals (13.5%) than in the relaxed group (2.8%; P ¼ 0.003), and significantly more participants in the relaxed group extended to and maintained 12-week treatment intervals (29.6%) than the intensive group (15.0%; P ¼ 0.005).Conclusions: Patients treated with a ranibizumab T&E protocol who tolerated some SRF achieved VA that is comparable, with fewer injections, with that achieved when treatment aimed to resolve all SRF completely.
The purpose of this review is to report and summarize previously reported studies and assess many of the individual steps of the intravitreal injection procedure’s possible effect on the prevention of endophthalmitis. The pooled endophthalmitis rate from 20 large retrospective case series of anti-VEGF injections was 144/510,396 (0.028%; 1/3,544). Injections may be performed in an office-based location or in an operating room (OR) and low rates of endophthalmitis can be achieved in either location with careful attention to asepsis. Pre- or post-injection topical antibiotics have not been shown to be effective, and could select for more virulent microorganisms. Povidone-iodine prior to injection is accepted as the gold-standard antiseptic agent, but aqueous chlorhexidine may be an alternative. Antisepsis before and after gel or subconjunctival anesthetic is suggested. The preponderance of Streptococcal infections after intravitreal injection is discussed, including the possible role of aerosolization, which can be minimized by using face masks or maintaining silence. As with other invasive procedures in medicine, the use of sterile gloves, following adequate hand antisepsis, may be considered. Control of the eyelashes and lid margin is required to avoid contamination of the needle, but this can be achieved with or without a speculum. Techniques to minimize vitreous reflux have not been shown to reduce the risk of endophthalmitis. Same day bilateral injections should be performed as two separate procedures, preferably using drug from different lots, especially when using compounded drugs.
Aqueous chlorhexidine was associated with a low rate of postinjection endophthalmitis and was well tolerated by patients.
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