scholarly journals Comparison Between Ranibizumab Biosimilar, Innovator Ranibizumab and Bevacizumab in a Real World Situation

Author(s):  
Dhanashree Ratra ◽  
Krishnakanta Roy ◽  
Sneha Giridhar ◽  
Sushant Madaan

Abstract PurposeTo analyze the efficacy of biosimilar ranibizumab as compared to innovator ranibizumab and bevacizumab.MethodsWe retrospectively analyzed consecutive patients treated with biosimilar ranibizumab for wet age related macular degeneration (AMD) and macular edema (ME) and compared them with ranibizumab and bevacizumab treated patients.ResultsOut of 202 patients, 67 (33.2%) received biosimilar ranibizumab (BSR), 69 (34.2%) ranibizumab (RBZ) and 66 (32.7%) bevacizumab (BEV). All patients received 3 consecutive injections followed by pro re nata dosing. The follow up ranged from 3 -24 months. The mean number of injections were 6.68 RBZ, 6.4 BEV and 4.7 BSR. At 3 months, nAMD (n=115, 56.9%) and ME (n= 87, 43.1%) groups showed significant improvement in vision and central foveal thickness (CFT) across all 3 agents. After ≥ 6 months, the effects were maintained in AMD group but not in ME group. Maximum effect was seen at 1 month. At no point of time, significant difference was noted among the 3 anti VEGF agents. No major safety concerns were noted.ConclusionsBiosimilar ranibizumab is comparable to innovator ranibizumab and bevacizumab in efficacy and safety. It can be added to the list of available anti VEGF agents for the treatment of vascular disorders.

2019 ◽  
Vol 4 (1) ◽  
pp. e000369 ◽  
Author(s):  
Henrik Faatz ◽  
Marie-Louise Farecki ◽  
Kai Rothaus ◽  
Matthias Gutfleisch ◽  
Daniel Pauleikhoff ◽  
...  

ObjectiveOptical coherence tomography angiography (OCT-A) enables detailed visualisation of the vascular structure of choroidal neovascularisation (CNV). The aim of this study was to determine whether mathematically ascertained OCT-A vascular parameters of type 1 and type 2 CNV in exudative age-related macular degeneration (AMD) change during antivascular endothelial growth factor (anti-VEGF) treatment. The OCT-A vascular parameters were also compared with previously obtained activity parameters (fluid distribution on spectral domain OCT (SD-OCT)) to establish whether they could potentially be used as further ‘activity parameters’ for assessment of anti-VEGF treatment.Methods and AnalysisWe evaluated 27 eyes of 27 patients (mean follow-up 9.8 months) with type 1, type 2 or mixed CNV who had received anti-VEGF treatment (IVAN scheme). The parameters analysed were area (aCNV), total length of all vessels (tlCNV), overall number of vascular segments (nsCNV) and fractal dimension (FD) of the CNV. The changes in each of these parameters were correlated with the central foveal thickness (CFT).ResultsRegression and renewed perfusion of the CNV corresponded with the decrease or increase, respectively, of macular fluid distribution on SD-OCT. The increase and decrease of CFT during anti-VEGF treatment were highly significantly correlated with changes in FD (p<0.00001), aCNV (p<0.00001), tlCNV (p<0.00001) and nsCNV (p<0.00001).ConclusionOCT-A enables detailed analysis of AMD with regard to FD, aCNV, tlCNV and nsCNV. As the changes in these parameters correlate closely with changes on SD-OCT, they can be used as new activity parameters, alongside fluid distribution, for assessment of treatment effect and as parameters of stabilisation or the need for repeated treatment.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Paolo Corazza ◽  
Francesco Maria D’Alterio ◽  
Jamil Kabbani ◽  
Mostafa Mohamed Ragheb Alam ◽  
Stefano Mercuri ◽  
...  

Abstract Purpose To describe real-life data from wet age-related macular degeneration (AMD) patients treated with anti-vascular endothelial growth factors (VEGFs) and to compare our results with previous studies and clinical trials. Methods This retrospective monocentric cohort study analyzed 865 eyes of 780 wet-AMD patients treated with an anti-VEGF treat-and-extend regimen over a long-term follow-up period. Aflibercept and Ranibizumab were considered first-line agents whereas Bevacizumab was reserved for use on a compassionate basis in patients not meeting treatment criteria. All patients underwent a best corrected visual acuity (BCVA) assessment at each follow-up visit. Results One-year follow-up figures were available for 82.5% of patients, whilst follow-up data was recorded for 55.6%, 37.6%, 25.1%, and 15.0% of the cohort at years 2, 3, 4, and 5 respectively. Patients treated with Bevacizumab received fewer yearly injections than those treated with Ranibizumab. However, no significant difference in the number of injections per year was detected in other comparisons between groups. Whilst our data showed no significant difference in mean BCVA between the three groups, there was a gradual deterioration of visual function over time for the patient cohort as a whole. Conclusion No significant differences between the 3 anti-VEGF molecules were recorded in wet-AMD patients in real-life conditions. Despite the long-term therapy, we found a slight reduction in visual function especially after the third year of treatment.


2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Ermete Giancipoli ◽  
Antonio Pinna ◽  
Francesco Boscia ◽  
Gianluigi Zasa ◽  
Giovanni Sotgiu ◽  
...  

Purpose. To evaluate the efficacy and safety of a single intravitreal dexamethasone implant (DXI) combined with intravitreal antivascular endothelial growth factor (anti-VEGF) therapy, in patients with neovascular age-related macular degeneration (wet-AMD) resistant to conventional treatment. Methods. In this randomized, controlled pilot study, 16 eyes of 15 patients, unresponsive to anti-VEGF therapy, were enrolled and randomly assigned to two groups: DXI + anti-VEGF (treatment group: 11 eyes) and monthly anti-VEGF alone (control group: 5 eyes). Patients were treated at baseline and followed for 6 months. Best corrected visual acuity (BCVA), optical coherence tomography (OCT) parameters, and fluorescein angiography (FA) were evaluated. Results. Eight eyes (72.7%) in the treatment group and 2 eyes in the control group (40%) showed complete retinal fluid resorption (p=0.049). BCVA showed no significant change from baseline in both the treatment group and the control group (p=0.40 and p=0.29, respectively). Both median central foveal thickness (CFT) and median macular volume showed a greater reduction from baseline in the treatment group. Conclusion. In patients showing an incomplete response to anti-VEGF therapy, DXI combined with intravitreal anti-VEGF seems to improve retinal fluid resorption without functional advantage. This trial is registered with ACTRN12618001102268.


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.


2021 ◽  
Vol 2 (4) ◽  
pp. 210-213
Author(s):  
Zheng-Feng Liu ◽  
◽  
Da-Dong Guo ◽  
Mei-Hua Ding ◽  
Hong-Sheng Bi ◽  
...  

AIM: To evaluate the one-year outcome of intravitreal conbercept injections for the treatment of choroidal neovascularization secondary to pathological myopia (pm-CNV) by optical coherence tomography angiography (OCTA). METHODS: The medical records of 26 consecutive eyes of 23 patients who received intravitreal injections of conbercept for pm-CNV with a follow-up of one year were retrospectively reviewed. All the patients were diagnosed by fundus fluorescein angiography (FFA) and OCTA at the first visit. All approaches were performed as “1+PRN” treatment. Outcomes included best-corrected visual acuity (BCVA), central foveal thickness (CFT) and the mean CNV area by OCTA. RESULTS: Mean Logarithm BCVA improved from (0.66±0.51) at baseline to (0.39±0.38) at one year (t=3.528, P=0.004). The CFT before treatment and after one year after were 275.08±48.74) μm and (205.15±43.74) μm respectively (t=4.630, P=0.001). The mean pm-CNV areas before treatment and after one year treatment were (0.48±0.24) mm2 and (0.15±0.11) mm2 respectively, with a significant difference among them (t=5.329, P=0.000). Twenty-one eyes had no needs after the first treatment. Four eyes received 2 injections and only one eye received 3 injections. No severe adverse events were noted relevant to the therapy. CONCLUSION: Intravitreal conbercept can improve the vision and relieve CFT and CNV area for the treatment of pm-CNV with “1+PRN” by OCTA for one year, however, long-term follow-up still need to be performed.


2021 ◽  
pp. bjophthalmol-2021-319054
Author(s):  
Brice Nguedia Vofo ◽  
Gala Beykin ◽  
Jaime Levy ◽  
Itay Chowers

AimsTo evaluate the long-term functional and anatomical outcomes of neovascular age-related macular degeneration (nvAMD) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) for up to 10 years, and to identify associated risk factors.MethodsClinical and optical coherence tomography findings were retrieved for nvAMD cases treated with intravitreal anti-VEGF compounds using a treat-and-extend protocol. In addition, the major risk alleles for AMD in the CFH (rs1061170), HTRA1 (rs1200638) and C3 (rs2230199) genes were genotyped.ResultsFrom 276 eligible eyes in 206 patients, 80 eyes (29%) in 66 patients (32.0%) had a follow-up period of ≥8 years and were included in this study. Over a 10-year period, 73.3±28.0 (mean±SD) anti-VEGF injections were administered. Best-corrected visual acuity (BCVA; LogMAR) deteriorated from 0.55±0.53 at baseline to 1.00±0.73 at 10 years (p<0.0005). Central subfield thickness (CST) decreased from 415.8±162.1 µm at baseline to 323±113.6 µm (p<0.0005) after three monthly injections and remained lower than baseline throughout the follow-up period. Visual outcome was associated with BCVA and intraretinal fluid (IRF) at baseline, macular atrophy, and macular thinning at follow-up. The decrease in CST was inversely correlated with the number of CFH and/or C3 risk alleles carried by the patient (Pearson’s r: −0.608; p=0.003).ConclusionsPatients with nvAMD who received anti-VEGF therapy for 10 years developed substantial vision loss associated with the presence of IRF at baseline and macular atrophy. Major risk alleles for AMD in two complement genes were associated with a reduced long-term reduction in macular thickness.


2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Jianqing Li ◽  
Jiayi Xu ◽  
Yiyi Chen ◽  
Jiaju Zhang ◽  
Yihong Cao ◽  
...  

Purpose. Intravitreal antivascular endothelial growth factor (anti-VEGF) therapy has been widely used for the treatment of neovascularization (NV) secondary to age-related macular degeneration (AMD). This study aimed to compare the efficacy among different subtypes of neovascular age-related macular degeneration (nAMD). Methods. PubMed, Embase, and the Cochrane Library were searched for eligible studies. We performed meta-analysis using Review Manager 5.3 and Stata/SE 12.0. Results. A total of 24 studies met our inclusion criteria and were included in the systematic review. At 3 months, the mean logarithm of the minimum angle of resolution (logMAR) improvements were −0.09, −0.18, and −0.23 for type 1, 2, and 3, respectively, while the mean macular thickness (MT) changes were −104.83, −130.76, and −196.29 μm. At 12 months, the mean changes in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters were 6.38, 8.12, and 9.37, while the MT decrease was 126.51, 126.52, and 139.85 μm, respectively. However, statistically significant difference was only found between type 1 and 3 in vision improvement, both in the short term (p=0.0002) and long term (p=0.01). Conclusions. The reactivity to VEGF inhibitors varied among different subtypes of nAMD. The efficacy of intravitreal anti-VEGF therapy in type 3 nAMD was statistically better than type 1 when considering vision improvement at 3 and 12 months. Thus, the lesion subtype is a predictor for the treatment outcome which can help guide prognosis.


2019 ◽  
Vol 4 (1) ◽  
pp. 6-12
Author(s):  
Zofia Michalewska ◽  
Jerzy Nawrocki

Purpose: This article studies visual outcome and frequency of antivascular endothelial growth factor (anti-VEGF) injections continued in patients with neovascular age-related macular degeneration (AMD) who had an earlier vitrectomy for postinjection endophthalmitis. Methods: A retrospective interventional study was conducted reviewing our database for patients with a diagnosis of endophthalmitis in the course of anti-VEGF injections. Endophthalmitis diagnosis was made on clinical examination of pain, rapid decrease in visual acuity (VA), conjunctival hyperemia, hypopyon, and vitritis. In all eyes, core vitrectomy with intravitreal antibiotics was performed. Spectral-domain optical coherence tomography was performed monthly before and after surgery during follow-up. Anti-VEGF injections were continued after surgery in all cases. Results: Eight eyes with postinjection endophthalmitis were included. Mean VA immediately before endophthalmitis was 20/50 Snellen with a mean of 19 intravitreal anti-VEGF injections ( P = .45). At time of endophthalmitis diagnosis, mean VA was 20/1000 (range, 20/2000-20/200). Mean time from injection to when the patient noted first symptoms was 4.3 days (range, 1-8 days). Mean time from first symptoms to surgery was 12 hours (range, 2.5-26 hours). Final mean VA at the end of follow-up (range, 12-84 months) did not statistically differ from VA at the visit immediately before endophthalmitis diagnosis ( P = .69). Mean frequency of injections after vitrectomy did not significantly differ from the presurgical course of treatment ( P =.97). Conclusions: Anti-VEGF treatment might be continued after vitrectomy for endophthalmitis and results in satisfactory anatomical and visual outcome. Surgery did not influence the frequency of anti-VEGF injections for neovascular AMD.


2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Joana Providência ◽  
Tiago M. Rodrigues ◽  
Mariana Oliveira ◽  
João Bernardes ◽  
João Pedro Marques ◽  
...  

Intravitreal injections of antivascular endothelial growth factors have been considered a milestone in the treatment of neovascular age-related macular degeneration (nAMD). However, the increasing incidence of AMD and the burden of visits and injections overcharge both the patient and the healthcare systems. Real-world solutions depend on treatment protocols aimed at optimizing the number of clinical visits while guaranteeing good functional outcomes. We performed a retrospective analysis of 72 eyes from 63 naïve patients diagnosed with nAMD that underwent a fixed intravitreal protocol consisting of bimonthly injections after a three-month loading dose, with either Aflibercept or Ranibizumab (no predefined criteria for treatment selection). Best corrected visual acuity (BCVA) and optical coherence tomography were analyzed at baseline and during follow-up clinical visits (months 3, 6, 12, and 18). From the included participants, 42 followed a fixed regimen with Aflibercept and 30 with Ranibizumab. At the 12-month visit, there was not a statistically significant difference in the mean change of BCVA between the two groups (p=0.121); however, the mean difference in the central retinal thickness was significantly superior in the Aflibercept group (-142.2 versus -51.5, p=0.011). The described fixed regimen seems to be efficient in the treatment of nAMD in a clinical practice setting.


2015 ◽  
Vol 233 (3-4) ◽  
pp. 146-154 ◽  
Author(s):  
Hyesun Kim ◽  
Sung Chul Lee ◽  
Sang Myung Kim ◽  
Ji Hwan Lee ◽  
Hyoung Jun Koh ◽  
...  

Purpose: To investigate the causes of acute spontaneous submacular hemorrhage with indocyanine green angiography (ICGA). Methods: Retrospective observation case series. A total of 51 eyes from 51 patients with newly developed spontaneous submacular hemorrhage were enrolled. Best-corrected visual acuity (BCVA), fundus photography, fluorescein angiography, spectral domain optical coherence tomography (OCT), and ICGA at baseline were analyzed. The extent of hemorrhage using fundus photography, height of hemorrhage, and central foveal thickness measured by OCT was analyzed to compare the diagnostic and nondiagnostic groups. Results: The mean logarithm of the minimum angle of resolution (logMAR) BCVA at presentation was 1.21 ± 0.74 (Snellen equivalent, 20/324); the mean follow-up period was 23.9 ± 23.9 months. The cause of submacular hemorrhage was diagnosed in 43 of 51 eyes (84.3%) based on ICGA at presentation. The initial diagnoses were correct in 93% of eyes. In 3 cases, the initial diagnosis of age-related macular degeneration (AMD) was changed to polypoidal choroidal vasculopathy (PCV) based on follow-up ICGA. The central foveal thickness was significantly greater in the nondiagnostic group (1,102.4 vs. 666.7 μm, respectively; p = 0.008). The most common cause of submacular hemorrhage was neovascular AMD (52.9%), followed by PCV (37.3%), macroaneurysm (5.9%), and lacquer crack (3.9%). The mean final visual acuity was generally worse in patients with submacular hemorrhage with typical AMD (visual acuity 20/618) or PCV (visual acuity 20/240) compared to that in patients with retinal macroaneurysm (visual acuity 20/100) or lacquer crack (visual acuity 20/72). Conclusions: ICGA at initial presentation helps identify causes of submacular hemorrhage, allowing differential treatment approaches that may improve outcomes and safety.


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