Switch to Aflibercept in the Treatment of Neovascular AMD: One-Year Results in Clinical Practice

2015 ◽  
Vol 233 (3-4) ◽  
pp. 155-161 ◽  
Author(s):  
João Pinheiro-Costa ◽  
José M. Costa ◽  
João N. Beato ◽  
Paulo Freitas-da-Costa ◽  
Elisete Brandão ◽  
...  

Purpose: To report the clinical outcomes of intravitreal aflibercept therapy in eyes with refractory and recurrent neovascular age-related macular degeneration (AMD) switched from intravitreal bevacizumab or ranibizumab. Methods: This is a retrospective review of eyes with neovascular AMD switched to intravitreal aflibercept with at least 1 year of follow-up after the switch. All patients had had a minimum of 3 injections of bevacizumab or ranibizumab before the switch. Aflibercept was used in patients considered refractory to bevacizumab (group 1) and in recurrent patients on therapy with ranibizumab due to an institutional policy decision (group 2). Changes in best-corrected visual acuity, fluid on optical coherence tomography (OCT), central retinal thickness (CRT) and the frequency of injections were compared. Results: Eighty-five eyes of 69 patients were analyzed, 39 eyes in group 1 and 46 in group 2. The mean follow-up time was 31.6 months prior to the switch and 14.7 months on treatment with aflibercept. One year after the switch, there was a nonsignificant mean decrease of 2 letters in visual acuity in both groups (group 1: from 58.2 to 55.8 letters, p = 0.086; group 2: from 56.4 to 54.5 letters, p = 0.168), but the mean number of injections per month was significantly lower (from 0.76 to 0.57, p < 0.001). With the switch, 90.6% of the patients showed anatomic improvement with a reduction of fluid on OCT, and both groups presented significant improvement in CRT (group 1: 65.3 µm, p = 0.051; group 2: 91.0 µm, p < 0.001). Conclusion: Aflibercept appears to be a valuable tool for the management of patients with poor responses to other anti-vascular endothelial growth factor drugs. These patients could have anatomic improvement, and the injection intervals could be extended.

2021 ◽  
Vol 62 (9) ◽  
pp. 1218-1226
Author(s):  
Gon Soo Choe ◽  
Jong Woo Kim ◽  
Chul Gu Kim ◽  
Jae Hui Kim

Purpose: To investigate the limited response to aflibercept after switching to aflibercept in neovascular age-related macular degeneration (AMD). Methods: This retrospective study included 70 eyes with neovascular AMD that were initially treated with ranibizumab and then switched to aflibercept. The incidence and timing of the limited response to aflibercept were identified and visual outcome was compared between eyes with and without limited response. In addition, factors predictive of limited response were analyzed. Results: A limited response to aflibercept was noted in approximately 1/5 of the patients who underwent switching to aflibercept in neovascular AMD. Switching to aflibercept was performed at a mean of 16.2 ± 12.7 months after diagnosis. During the mean 34.7 months of follow-up after switching, limited response was noted in 15 eyes (21.4%) at a mean of 22.0 ± 13.9 months after switching. The degree of reduction in visual acuity was mean logMAR 0.34 ± 0.41 in eyes with limited response and mean 0.06 ± 0.20 in eyes without (p = 0.002). In addition, the duration between the diagnosis and the switching was shorter (p = 0.012), and the number of ranibizumab injections before switching was lower (p = 0.016) in eyes with limited response than in eyes without. Conclusions: Patients who showed limited response to aflibercept after switching to aflibercept showed a worse visual outcome. The probability of having a limited response is higher when the switching is performed earlier.


2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Ricardo P. Casaroli-Marano ◽  
Carolina Bernal-Morales ◽  
Lillian Chamorro-López ◽  
Marina Dotti-Boada ◽  
Juan P. Figueroa-Vercellino ◽  
...  

The current treatment of neovascular age-related macular degeneration (nAMD) generates an excessive care pressure in the public health system. The search for a satisfactory treatment regimen, whose anatomical and functional stability may be achieved, is a challenge and a goal to be reached. We analyzed the outcomes in a patient cohort under fixed regimen treatment with intravitreal aflibercept (IVA). A retrospective study, with at least 1-year follow-up, in consecutive treated unselected naïve patients was carried out. Standard protocol was performed and evaluated at baseline, month 4 (after loading dose, LD), and month 12 (after fixed bimonthly regimen). One hundred six patients (123 eyes) aged 80.3 ± 7.7 years were included, receiving 6.8 ± 0.7 IVA. Visual acuity gain after LD was 5.5 ± 12.0 letters ( p < 0.0001 ). At month 12, 23 eyes (18.7%) gained ≥15 letters and 58 (47.1%) had best-corrected visual acuity ≥20/40 (70 letters). The improvement in visual acuity was lower in patients with polypoidal choroidal vasculopathy (+4.9 ± 18.1 letters; p = 0.2544) and somewhat higher in patients with retinal angiomatous proliferation (+5.4 ± 12.3 letters; p = 0.0373 ). Dry macula was present in only 9.8% of cohort at baseline vs. 69.7% at month 12 ( p < 0.0001 ). Atrophy was the most observed complication and related to the elderly patients. The average of follow-up visits was 3 ± 0.5. Functional and anatomical improvement were observed with IVA in a fixed bimonthly regimen treatment after LD, with results maintained up to one year with a good compliance. The fixed bimonthly regimen optimized patient management and logistic issues.


2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Fenghua Wang ◽  
Yuanzhi Yuan ◽  
Ling Wang ◽  
Xiaofeng Ye ◽  
Jingke Zhao ◽  
...  

Purpose. To compare the functional and anatomical outcomes of one dose and three loading doses followed by the pro re nata (PRN) regimen in Chinese neovascular age-related macular degeneration (nvAMD) (including polypoidal choroidal vasculopathy (PCV)) patients. Methods. In this multicenter, prospective, open-label, controlled, 12-month study (ClinicalTrials.gov: NCT02810808), patients were randomized (1 : 1) to 1 dose + PRN (PRN group) or 3 loading doses + PRN (LD group) using intravitreal ranibizumab treatment. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated. The main outcome was the change in BCVA. The noninferiority limit was 5 letters. Results. Forty-five patients in the PRN group and 49 patients in the LD group finished 12-month follow-up. Each group included 4 PCV patients. The mean change in BCVA from baseline was 7.8 letters in the PRN group, compared with 10.9 letters in the LD group (P=0.344). There were no significant differences between two groups in the mean change of CRT (−159.3 μm vs. −120.5 μm) at month 12. The mean number of injections during the 12-month follow-up was 6.0 in the PRN group and 6.8 in the LD group. The proportion of patients who gained an improvement in visual acuity by 15 or more letters was 28.9% in the PRN group and 44.9% in the LD group (P=0.066). Conclusion. One dose + PRN showed noninferior visual gains than 3 loading doses + PRN regimen using ranibizumab in Chinese nvAMD and PCV patients. Number of injections in the PRN group was similar as that in the LD group but remained a potential risk of vision instability during one-year follow-up using OCT-guided retreatment criteria. This trial is registered with NCT02810808.


2020 ◽  
Vol 20 (4) ◽  
pp. 209-215
Author(s):  
A.V. Kuroyedov ◽  
◽  
O.V. Gapon’ko ◽  
V.V. Gorodnichiy ◽  
I.V. Kondrakova ◽  
...  

Aim: to assess the effectiveness and tolerability of anti-VEGF agents, aflibercept (2.0 mg) and ranibizumab (0.5 mg), in the combined treat-ment for wet age-related macular degeneration (AMD) in routine clinical practice.Patients and Methods: 55 patients (65 eyes) with the late stage of wet AMD were divided into two groups. Group 1 included 32 eyes with classic choroidal neovascularization (CNV) and group 2 included 33 eyes with occult CNV. Best-corrected visual acuity (BCVA), intraocular pressure, and retinal nerve fiber layer (RNFL) thickness were measured. These parameters were compared at different time points during the treatment.Results: overall AMD duration (January 2019) was 36 (19; 47) months being 30 (12; 44) months in group 1 and 36 (23; 48) months in group 2 (р>0.05). The first intravitreal administration of an anti-VEGF drug was performed 7.5 (3.5; 9.5) months after AMD diagnosis in group 1 and 7 (3; 11) months after AMD diagnosis in group 2. Significant differences in intragroup intervals were revealed between various follow-up periods. More differences were identified for the intervals between intravitreal administrations in group 2. Baseline and final BCVA during the entire follow-up which was 29.5 (19.5; 38) months in group 1 and 28 (25; 44) months in group 2 demonstrated neither intragroup nor intergroup differences (р>0.05). Conclusion: our management strategy for wet AMD is somewhat different from conventional guidelines. However, it has no significant impact on visual acuity during the follow-up.Keywords: age-related macular degeneration, anti-VEGF drugs, intravitreal administration, IOP level, aflibercept, ranibizumab.For citation: Kuroyedov A.V., Gapon’ko O.V., Gorodnichiy V.V. et al. Effectiveness and tolerability of the combined use of anti-VEGF agents in clinical practice. Russian Journal of Clinical Ophthalmology. 2020;20(4):209–215. DOI: 10.32364/2311-7729-2020-20-4-209-215.


2017 ◽  
Vol 1 (1) ◽  
pp. oapoc.0000021
Author(s):  
Jean-Julien Keppi ◽  
Benjamin Wolff ◽  
Laurent Castelnovo ◽  
Guillaume Michel ◽  
Claude Speeg-Schatz ◽  
...  

Purpose To compare pro re nata (PRN) and bimonthly intravitreal aflibercept injection protocols in the treatment of neovascular age-related macular degeneration (nAMD). Methods This was a retrospective, observational, comparative study in 2 centers. All study patients presented with newly diagnosed nAMD and were treated as follows after an induction of 3 consecutive monthly loading doses: the bimonthly group was retreated every 2 months and followed up every 4 months while the PRN group was retreated in case of subretinal exudation or visual acuity decrease and followed up every month. A comprehensive ophthalmic examination was performed at each study visit. Results At 1 year, 34 eyes were analyzed. The 19 patients in the bimonthly group had a mean visual acuity improvement of +8.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters whereas stabilization was observed in the PRN group (-0.47 ETDRS letters; p = 0.027). All patients in the bimonthly group had 4 follow-up visits and 7.5 injections whereas the mean number of follow-up visits in the PRN group (15 patients) was 7.8 with 7.6 injections. Conclusions Our study suggests that a fixed bimonthly aflibercept retreatment protocol may provide better visual results than a PRN protocol.


Author(s):  
Alaa Din Abdin ◽  
Asem Mohamed ◽  
Cristian Munteanu ◽  
Isabel Weinstein ◽  
Achim Langenbucher ◽  
...  

Abstract Background To assess the morphological and functional outcome of intravitreal aflibercept following the treat and extend protocol compared to the fixed protocol for treatment of eyes with neovascular age-related macular degeneration. Methods This retrospective study included 126 eyes of 113 patients with primary onset neovascular age-related macular degeneration who were followed for 12 months. All eyes were treated with 2 mg/0.05 mL aflibercept. All eyes received an upload with three monthly aflibercept injections. We subsequently studied two groups of eyes. For group 1, 54 eyes were treated following the treat and extend protocol. For group 2, 72 eyes were treated following the fixed protocol (fixed 2-monthly interval). Main outcome measures included: best corrected visual acuity (BCVA), central macular thickness (CMT) and number of injections. Results BCVA (logMAR) in group 1 vs group 2 was (0.61 ± 0.3 vs 0.72 ± 0.3, p = 0.09) before treatment and (0.48 ± 0.3 vs 0.51 ± 0.3, p = 0.6) after one year of treatment. CMT in group 1 vs group 2 was (371 ± 101 μm vs 393 ± 116 μm, p = 0.5) before treatment and (284 ± 60 μm vs 290 ± 67 μm, p = 0.1) after one year of treatment. Number of injections/eye in group 1 vs group 2 was (8.5 ± 2.2 vs 7.0 ± 0, p < 0.001). Conclusions Significant differences regarding BCVA and central macular thickness were not found between both treatment protocols during the first year of treatment using aflibercept. However, a significantly higher number of injections was needed for eyes in the treat and extend group during the first year of treatment. This might suggest that aflibercept should better not be extended past an 8 weeks interval during the first year of treatment. Study registration This study was approved by the Ethics Committee of the Medical Association of Saarland, Germany (Nr. 123/20, Date: 16.06.2020). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.


2017 ◽  
Vol 1 (2) ◽  
pp. 109-115
Author(s):  
Daniel R. Moroz ◽  
Monique Munro ◽  
Michael P. Fielden

Purpose: To determine whether the presenting clinical features of active myopic choroidal neovascularization (CNV), including the presence of fibrosis or atrophy, limit the ultimate visual acuity gains from intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy. Methods: A retrospective analysis of 42 eyes with new-onset subfoveal CNV was performed. Only patients without concurrent age-related macular degeneration and with a spherical equivalent of at least −6.0 diopters were included in the study. All eyes received either intravitreal ranibizumab or bevacizumab injections as the primary treatment on a pro re nata basis for 1 year. Changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were recorded. Results: The mean number of ranibizumab (18 eyes) or bevacizumab (24 eyes) injections was 4.7 ± 0.5 over a mean follow-up time of 12 ± 0.4 months. The mean age of the patients was 62 ± 2.0 years. Based on optical coherence tomography staging at the initiation of treatment for active CNV, 30 had no fibrosis or atrophy (group 1), 5 had fibrotic stage, and 7 had atrophic stage CNV (the latter combined to form group 2). The BCVA for group 1 improved significantly ( P < .02) but worsened for group 2 ( P < .38), a statistically significant difference ( P < .05). The CRT for group 1 also declined significantly more than for group 2 ( P < .014). Conclusion: The presence of fibrosis or atrophy in eyes with active myopic CNV at the initiation of anti-VEGF therapy was associated with limited anatomic outcomes and visual gain.


2021 ◽  
Vol 11 (10) ◽  
pp. 1024
Author(s):  
Timothy Y. Y. Lai ◽  
Ricky Y. K. Lai

Previous studies based on clinical trial data have demonstrated that greater fluctuations in retinal thickness during the course of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy for neovascular age-related macular degeneration (nAMD) is associated with poorer visual acuity outcomes. However, it was unclear whether similar findings would be observed in real-world clinical settings. This study aimed to evaluate the association between retinal thickness variability and visual outcomes in eyes receiving anti-VEGF therapy for nAMD using pro re nata treatment regimen. A total of 64 eyes which received intravitreal anti-VEGF therapy (bevacizumab, ranibizumab or aflibercept) for the treatment of nAMD were evaluated. Variability in spectral-domain optical coherence tomography (OCT) central subfield thickness (CST) was calculated from the standard deviation (SD) values of all follow-up visits after three loading doses from month 3 to month 24. Eyes were divided into quartiles based on the OCT CST variability values and the mean best-corrected visual acuity values at 2 years were compared. At baseline, the mean ± SD logMAR visual acuity and CST were 0.59 ± 0.39 and 364 ± 113 µm, respectively. A significant correlation was found between CST variability and visual acuity at 2 years (Spearman’s ρ = 0.54, p < 0.0001), indicating that eyes with lower CST variability had better visual acuity at 2 years. Eyes with the least CST variability were associated with the highest mean visual acuity improvement at 2 years (quartile 1: +9.7 letters, quartile 2: +1.1 letters, quartile 3: −2.5 letters, quartile 4: −9.5 letters; p = 0.018). No significant difference in the number of anti-VEGF injections was found between the four CST variability quartile groups (p = 0.21). These findings showed that eyes undergoing anti-VEGF therapy for nAMD with more stable OCT CST variability during the follow-up period were associated with better visual outcomes. Clinicians should consider adopting treatment strategies to reduce CST variability during the treatment course for nAMD.


2009 ◽  
Vol 19 (4) ◽  
pp. 535-543 ◽  
Author(s):  
Leopoldo Spadea ◽  
Massimo Saviano ◽  
Angela Di Gregorio ◽  
Domenico Di Lodovico ◽  
Fabio De Sanctis

Purpose To evaluate in a long-term period the effectiveness and safety of topographically guided two-step laser in situ keratomileusis (LASIK) and standard LASIK technique in the correction of refractive errors after successful penetrating keratoplasty (PKP) for keratoconus. Methods At least 2 years after PKP and 6 months after removal of all sutures, 15 eyes of 15 patients (Group 1; mean manifest refraction spherical equivalent (MRSE) −7.23 D ± 3.42 SD) were submitted to standard LASIK and 15 eyes of 15 patients (Group 2; mean MRSE −4.37 D ± 1.97 SD) to a topographically guided two-step LASIK procedure (first the flap and at least 2 weeks later the laser ablation). In all cases, a superior hinged corneal flap (160 μm/9.5 mm) was created. Results After a follow-up of 36 months, in Group 1 the mean uncorrected visual acuity (UCVA) was 0.51 logarithm of the minimum angle of resolution (logMAR) ± 0.41 SD and the mean best-corrected visual acuity (BCVA) was 0.03 logMAR ± 0.05 SD, with a mean MRSE of −1.57 D ± 2.65 SD. In Group 2, the mean UCVA was 0.28 logMAR ± 0.24 SD and the mean BCVA was 0.01 logMAR ± 0.03 SD, with a mean MRSE of −0.07 D ± 1.00 SD. In both groups, no complications were observed. Conclusions After a long follow-up period, both topographically guided two-step LASIK and standard LASIK could be considered effective and safe tools in the correction of refractive errors after successful PKP for keratoconus.


2019 ◽  
Vol 4 (1) ◽  
pp. e000109 ◽  
Author(s):  
Michel Weber ◽  
Laurent Velasque ◽  
Florence Coscas ◽  
Céline Faure ◽  
Isabelle Aubry ◽  
...  

Background/aimsTo monitor treatment-naïve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.MethodsRAINBOW (Real life use of intravitreal Aflibercept In FraNce - oBservatiOnal study in Wet age-related macular degeneration) is an ongoing, observational, retrospective and prospective 4-year study to assess visual (primary), anatomical and safety outcomes following IVT-AFL treatment in wet AMD patients. We report the interim 12-month outcomes in patients who have already been enrolled.ResultsSafety data were analysed from 586 patients (safety analysis set); and effectiveness data were analysed from 502 patients with at least one follow-up (full-analysis set) and from 353 patients with visual acuity data at baseline and month 12. The mean (SD) best-corrected visual acuity (BCVA) was 56.7 (18.2) letters and the mean (SD) central retinal thickness (CRT) was 395.6 (140.5)µm at baseline. Most patients (76.9%) received a loading dose (first three injections within 90 days). The mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1) and 6.6 (1.8) (patients who received a loading dose). The mean (SD) change in BCVA was 5.5 (15.0) letters and 6.8 (14.5) letters (patients who received a loading dose) at month 12 (p<0.001 vs baseline). The mean (SD) CRT reduction was –108.7 (146.8)µm and –116.4 (150.4)µm (loading dose) at month 12 (p<0.001 vs baseline). Overall, 118 (20.1%) patients experienced at least one treatment-emergent adverse event (TEAE), 1.2% experienced ocular TEAEs and 3.9% experienced serious AEs.ConclusionThis 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in a real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.Trial registration numberNCT02279537 Pre-results.


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