scholarly journals One-Year Outcomes of 1 Dose versus 3 Loading Doses Followed by Pro Re Nata Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration: The ARTIS Trial

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.

2016 ◽  
Vol 2016 ◽  
pp. 1-5
Author(s):  
Yingyi Lu ◽  
Jianfeng Huang ◽  
Jing Zhao ◽  
Xiaobing Yu ◽  
Li Long ◽  
...  

Purpose. To observe the effect of intravitreal ranibizumab injection on wet age-related macular degeneration (wAMD) over 5 years in Chinese patients. Methods. Thirty-seven patients who were diagnosed with wAMD in our hospital from June 2007 to June 2014 were retrospectively reviewed. The PRN regimen and the treatment and extend regimen were applied. Best corrected visual acuity (BCVA), number of ranibizumab injections, and changes in the choroidal neovascularization (CNV) lesion over 5 years were analyzed. Results. The mean BCVA measured by the ETDRS chart at baseline was 47.4 and 5 years after the treatment it was 34.89 letters, which was significantly different (p=0.013). Fourteen eyes (37.8%) had improved visual acuity after 5 years. The number of injections in 5 years was 11.53, and most of the injections were in the first two years. Seventeen (45.9%) cases developed fibrous lesions, and 2 (5.4%) cases had atrophic lesions after 5 years. The fibrosis/atrophy was significantly correlated with the injection numbers (Pearson, r=0.663, and p=0.000). Conclusion. Most of the patients can maintain visual acuity treated by ranibizumab in the first 3 years. After 5 years, some patients can still improve or maintain visual acuity. Fibrous scarring of the lesion is the main reason for a decrease in vision of wAMD patients.


2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Kang-Jung Lo ◽  
Jin-Yu Chang ◽  
Hsin-Yi Chang ◽  
Shih-Hwa Chiou ◽  
De-Kuang Hwang ◽  
...  

Purpose. To observe and analyze the long-term outcomes of patients with neovascular age-related macular degeneration (nAMD) treated with aflibercept monotherapy under the National Health Insurance (NHI) program in Taiwan. Methods. This retrospective observational study was conducted at Taipei Veterans General Hospital. Patients with naive nAMD who were treated with aflibercept and followed for more than 3 years were reviewed. The better eye was enrolled if both eyes were affected. Visual acuity (VA) and central macular thickness (CMT) were recorded for 3 years. The lost-to-follow-up rate, number of injections, and predictive factors for visual outcomes were analyzed. Results. Ninety-nine eyes in 99 patients were followed up for 3 years. The mean age at onset of nAMD was 82.8 ± 9.26 years, and 65% of the patients were male. Compared with initial visual acuity, 5 (5.1%) of our patients improved their vision for 3 or more lines after 3 years of follow-up, 11 (11.1%) of our patients improved for 1 to 3 lines, 62 (62.6%) patients remained their vision with 1 line or less changes, 15 (15.2%) patients lost their vision for 1 to 3 lines, and 6 (6%) patients lost their vision for 3 or more lines. The CMT was 359 ± 180 µm before treatment and 259 ± 98 after 3 years (p<0.001). The mean number of injections was 4.63 ± 1.91 in the first year, 2.13 ± 2.2 in the second year, and 1.42 ± 1.79 in the third year. Multivariate analysis showed that final VA was significantly associated with VA at year 1, the presence of retinal pigment epithelial detachment at year 1, and receiving more than four injections in the first year. Final CMT was only significantly associated with CMT at year 1. Conclusion. After 3 years of treatment under the NHI program in Taiwan, 21.2% of the patients with nAMD still had a visual decline despite good anatomical outcomes. More aggressive treatment or other strategies should be used for patients who may have a poor prognosis.


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.


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.


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.


2014 ◽  
Vol 7 (4) ◽  
pp. 13-21
Author(s):  
Yuriy Sergeyevich Astakhov ◽  
Gassan Basharovich Shaar ◽  
Nikita Yur’yevich Dal’

Purpose. To study the effects of vitrectomy on the course of wet age-related macular degeneration (AMD). Materials and methods. 99 patients (99 eyes) with wet AMD associated with vitreo-macular adhesion or posterior hyaloid traction were included in the study. During the first 6 months, all patients received anti-VEGF treatment according to a PRN regimen. Then, they were divided into two groups: in 45 patients vitrectomy was performed and 54 patients did not receive surgical treatment. The follow-up period duration was one year. Results. At the beginning of the study, visual acuity was 0.27 ± 0.17 in the control group, and 0.17 ± 0.15 in the treatment group. Most prominent differences in visual acuity between the two groups were observed during the first 6 months (visual acuity in the treatment group before surgery was 0.12 ± 0.1) (p < 0.01 and p < 0.001), at the same time during the following 6 follow-up months, this difference decreased (p < 0.05 and p < 0.01). 1 year from the study start, visual acuity in the control group was 0.24 ± 0.17, and 0.17 ± 0.13 in the treatment one. Conclusions. Vitrectomy surgery in patients with wet AMD in association with vitreo-macular adhesion or posterior hyaloid traction does not exacerbate the disease course, stabilizes visual functions and improves the quality of life.


2021 ◽  
pp. 112067212110057
Author(s):  
Pierre Gascon ◽  
Prithvi Ramtohul ◽  
Charles Delaporte ◽  
Sébastien Kerever ◽  
Danièle Denis ◽  
...  

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.


QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
M S Abdaltawab ◽  
Z F Ismail ◽  
W M A Ebeid ◽  
S M Fawzy

Abstract Aim of the Work The aim of this work is to compare the response of treatment with ranibizumab in terms of visual acuity in cases of CNV secondary to pathological myopia versus CNV secondary to age-related macular degeneration. Methods This prospective, comparative study included ten eyes newly diagnosed as having CNV secondary to pathological myopia, and 10 eyes newly diagnosed as having subfoveal active CNV secondary to AMD. All patients had 3 monthly intravitreal Injections of 0.50 mg (in 0.05 ml of solution) ranibizumab with monthly evaluation of best corrected visual acuity (BCVA) by Landolt C chart, and also calculated in Logarithm of Minimum Angle of Resolution (Log MAR). Results pretreatment there was no significant difference between the two groups as the mean VA (Log Mar) was 1.31 ± 0.2 in AMD group and 1.17 ± 0.3 in MCNV group of P value = 0.431 and also post three IVI of ranibizumab showed no significant difference between the two groups as the mean VA (Log Mar) was 1.22 ± 0.2 for AMD and 1.22 ± 0.5 for MCNV of P value = 0.635. Conclusion there was no significant difference in BCVA between AMD and MCNV groups after three intravitreal injections of ranibizumab.


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.


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