Efficacy of aflibercept for the treatment of chronic non-ischemic CRVO-associated macular edema after treatment with other anti- VEGF agents (original) (raw)
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International Journal of Retina and Vitreous, 2019
Background Diabetic macular edema (DME) is an important cause of vision loss and despite the anatomical and functional improvement achieved with treatment, there are reports of persistent DME regardless of continuous anti-VEGF therapy. The purpose of this study is to examine the effect of patients with DME previously treated with other anti-VEGF agents who are transitioned to intravitreal aflibercept (IAI) on a fixed dosing regimen. Methods This prospective study included 20 patients presenting with DME with a history of previous anti-VEGF treatment with ranibizumab or bevacizumab. Patients received a 2 mg (0.05 mL) IAI every 4 weeks until no evidence of fluid by optical coherence tomography (OCT) followed by a fixed dosing schedule of 2 mg IAI once every 8 weeks through 24 months. There was a pre-planned interim analysis of the mean absolute change from baseline central foveal thickness at month 6 as measured by OCT. Secondary outcomes included mean change from baseline in ETDRS vi...
Purpose: To provide 2-year results comparing antievascular endothelial growth factor (VEGF) agents for center-involved diabetic macular edema (DME) using a standardized follow-up and retreatment regimen. Design: Randomized clinical trial. Participants: Six hundred sixty participants with visual acuity (VA) impairment from DME. Methods: Randomization to 2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, or 0.3-mg ranibizumab intravitreous injections performed up to monthly using a protocol-specific follow-up and retreatment regimen. Focal/grid laser photocoagulation was added after 6 months if DME persisted. Visits occurred every 4 weeks during year 1 and were extended up to every 4 months thereafter when VA and macular thickness were stable. Main Outcome Measures: Change in VA, adverse events, and retreatment frequency. Results: Median numbers of injections were 5, 6, and 6 in year 2 and 15, 16, and 15 over 2 years in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P ¼ 0.08). Focal/grid laser photocoag-ulation was administered in 41%, 64%, and 52%, respectively (aflibercept vs. bevacizumab, P < 0.001; afli-bercept vs. ranibizumab, P ¼ 0.04; bevacizumab vs. ranibizumab, P ¼ 0.01). At 2 years, mean VA improved by 12.8, 10.0, and 12.3 letters, respectively. Treatment group differences varied by baseline VA (P ¼ 0.02 for interaction). With worse baseline VA (20/50 to 20/320), mean improvement was 18.1, 13.3, and 16.1 letters, respectively (aflibercept vs. bevacizumab, P ¼ 0.02; aflibercept vs. ranibizumab, P ¼ 0.18; ranibizumab vs. bevacizumab, P ¼ 0.18). With better baseline VA (20/32 to 20/40), mean improvement was 7.8, 6.8, and 8.6 letters, respectively (P > 0.10, for pairwise comparisons). Anti-Platelet Trialists' Collaboration (APTC) events occurred in 5% with aflibercept, 8% with bevacizumab, and 12% with ranibizumab (global P ¼ 0.047; aflibercept vs. bevacizumab, P ¼ 0.34; aflibercept vs. ranibizumab, P ¼ 0.047; ranibizumab vs. bevacizumab, P ¼ 0.20; global P ¼ 0.09 adjusted for potential confounders). Conclusions: All 3 anti-VEGF groups showed VA improvement from baseline to 2 years with a decreased number of injections in year 2. Visual acuity outcomes were similar for eyes with better baseline VA. Among eyes with worse baseline VA, aflibercept had superior 2-year VA outcomes compared with bevacizumab, but superiority of aflibercept over ranibizumab, noted at 1 year, was no longer identified. Higher APTC event rates with ranibizumab over 2 years warrants continued evaluation in future trials.
JAMA Ophthalmology, 2019
IMPORTANCE The comparative clinical effectiveness of ranibizumab, aflibercept, and bevacizumab for the management of macular edema due to central retinal vein occlusion (CRVO) is unclear. OBJECTIVE To determine whether intravitreal aflibercept or bevacizumab compared with ranibizumab results in a noninferior mean change in vision at 100 weeks for eyes with CRVO-related macular edema. DESIGN, SETTING, AND PARTICIPANTS This prospective, 3-arm, double-masked, randomized noninferiority trial (Lucentis, Eylea, Avastin in Vein Occlusion [LEAVO] Study) took place from December 12, 2014, through December 16, 2016, at 44 UK National Health Service ophthalmology departments. Inclusion criteria included age 18 years or older, visual impairment due to CRVO-related macular edema of less than 12 months with best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score (approximate Snellen equivalent) in the study eye between 19 (20/400) and 78 (20/32), and spectral domain optical coherence tomography imaging central subfield thickness of 320 μm or greater. Data were analyzed from March 4, 2019, to April 26, 2019. INTERVENTIONS Participants were randomized (1:1:1) to receive repeated intravitreal injections of ranibizumab (0.5 mg/0.05 mL) (n = 155), aflibercept (2.0 mg/0.05 mL) (n = 154), or bevacizumab (1.25 mg/0.05 mL) (n = 154) for 100 weeks. MAIN OUTCOMES AND MEASURES Adjusted mean change in BCVA in the study eye at 100 weeks wherein noninferiority was concluded if the lower bounds of the 95% CI of both the intention-to-treat and the per protocol analyses were above-5 letters. RESULTS Of 463 participants, 265 (57.2%) were male, with a mean (SD) age of 69.1 (13.0) years. The mean (SD) gain in BCVA letter score was 12.5 (21.1) for ranibizumab, 15.1 (18.7) for aflibercept, and 9.8 (21.4) for bevacizumab at 100 weeks.
Expert Review of Clinical Pharmacology
Introduction: Anti-vascular endothelial growth factor (VEGF) therapy has become the most commonly used treatment for macular edema secondary to retinal vein occlusion (RVO). Although its superior efficacy as compared to other interventions has been proven, there is a lack of evidence for relative efficacy among anti-VEGF drugs. Areas covered: This work systematically reviewed and compared the efficacy of intravitreal bevacizumab, ranibizumab, and aflibercept for treating macular edema due to RVO. PubMed, EMBASE, and the Cochrane Library were searched from their inception until October 2017. Eleven randomized controlled trials (18 articles; 1830 adult patients) were identified. The proportion of patients who gained at least 15 letters in best-corrected visual acuity (BCVA), mean change from baseline in BCVA, and mean change from baseline in central macular thickness (CMT) were reported and these efficacy outcomes at 6 months were analyzed in network meta-analysis. Expert commentary: Apparently, bevacizumab, ranibizumab, and aflibercept were significantly superior to sham injection in terms of BCVA improvement and CMT reduction and had good safety profiles. However, there were no statistically significant differences in any outcomes among anti-VEGF drugs. In selecting an anti-VEGF drug for individual patients, other factors including affordability, drug availability, and patient characteristics should be considered.
International journal of ophthalmology, 2014
To compare the efficacy of ranibizumab and bevacizumab for macular edema due to retinal vein occlusion (RVO). A retrospective study was conducted at a single academic institution. Eighty-one patients naïve to anti-VEGF therapy with RVO and macular edema were identified. Twenty-six eyes were treated with ranibizumab, 33 eyes with bevacizumab, and 22 eyes with bevacizumab then switched to ranibizumab (crossover). The main outcome was change in visual acuity at 3 months, 6 months, and final visit. The mean visual acuity improved from 20/80 to 20/40 in the ranibizumab (R) group and from 20/125 to 20/60 in the bevacizumab (B) group (P=0.66). The mean change in central subfield thickness (CST) was -186 and -212µm, respectively (P=0.69). Mean time between injections was 94±21.1d in the R group and 103.8±10.5d in the B group (P=0.78). In the crossover group, mean initial visual acuity was 20/125, reached 20/60 at crossover, and remained 20/60 at conclusion (P=0.91). Both ranibizumab and bev...
BMC Ophthalmology
Background Anti–vascular endothelial growth factor (anti-VEGF) agents have become the standard of care in neovascular age-related macular degeneration (nAMD). Despite generally excellent response rates to anti-VEGF therapy, some patients do not respond or may respond suboptimally. In the case of refractory or rapidly recurring fluid in nAMD, clinicians may switch to another anti-VEGF agent. TITAN was an observational study that assessed the effectiveness and safety of intravitreal aflibercept (IVT-AFL) in patients with nAMD refractory to ranibizumab who switched to IVT-AFL after less than 12 months of ranibizumab treatment in routine clinical practice in France. Methods TITAN was an observational, retrospective and prospective 12-month study conducted at 28 centres in France. Patients with nAMD refractory to ranibizumab were enrolled. Patients who were switched from ranibizumab to IVT-AFL were followed for 12 months. Data were obtained from medical records for retrospectively includ...
American Journal of Ophthalmology, 2013
Purpose-To report results of aflibercept therapy in eyes with neovascular age-related macular degeneration previously treated with bevacizumab and/or ranibizumab. Design-Retrospective, interventional, non-comparative, consecutive case series Methods-Ninety-six eyes, 85 patients, with neovascular AMD that had previously received bevacizumab and/or ranibizumab were treated with aflibercept monthly for 3 months followed by a fourth injection within 2 months. Outcomes were determined 4 ± 1 months after the first aflibercept dose and included: proportion of patients gaining or losing ≥ 2 lines of best corrected visual acuity (BCVA), proportion remaining within ±1 line, mean change in logMAR VA, mean change in central foveal thickness, mean change in macular cube volume, and qualitative anatomic response as assessed by spectral-domain OCT. Results-At baseline, 82 (85%) eyes had signs of active exudation despite a mean 17 previous anti-VEGF injections. At final visit, 82 (85%) remained stable within ±1 line, 7 (7%) gained and 7 (7%) lost ≥ 2 lines of BCVA. Mean logMAR VA showed minimal change 0.02 (range −0.46 to 0.70, P=0.14). Mean central foveal thickness decreased −18 microns (range −242 to 198, P=0.06). Mean macular volume decreased −0.27 mm 3 (95% CI, −0.4 to −0.1, P = 0.004). On qualitative analysis, 4 (5%) eyes had complete resolution of exudative fluid, 40 (49%) partially resolved, 26 (32%) remained unchanged, and 12 (14%) worsened. Conclusion-Aflibercept appears to be an effective alternative for neovascular AMD patients previously treated with bevacizumab and/or ranibizumab at 4 months follow-up. The majority of treated eyes demonstrated stable VA and anatomic improvements by SD-OCT.
Asia-Pacific Journal of Ophthalmology, 2020
Purpose: The aim of this study was to examine 12-month outcomes of eyes switched from intravitreal ranibizumab or bevacizumab to aflibercept for cystoid macular edema due to retinal vein occlusion (RVO). Design: Retrospective, observation, case series. Methods: A retrospective study was performed assessing eyes with RVO switched to aflibercept for at least 12 months. To be included in the study, eyes had to have macular edema despite treatment for at least 6 months with bevacizumab and/or ranibizumab before the switch, central foveal thickness (CFT) ≥300 μm at time of switch, and visual acuity (VA) ≤60 early treatment of diabetic retinopathy score (ETDRS) letters (20/40 Snellen equivalent). Outcome measures included change in VA (in ETDRS letters), CFT, and interval between intravitreal injections. Results: 27 eyes of 27 patients were included in the analysis: 13 with branch RVO, and 14 with central RVO. Mean VA before switch was 54.2 ± 23.7 letters (20/80 Snellen equivalent) and me...