scholarly journals Intraocular Injection of Stivant® (A Biosimilar to Bevacizumab): A Case Series

Author(s):  
Ahmad Mirshahi ◽  
Alireza Lashay ◽  
Hamid Riazi-Esfahani ◽  
Nazanin Ebrahimiadib ◽  
Hassan Khojasteh ◽  
...  

Purpose: To report the results of intravitreal injection of a bevacizumab biosimilar called Stivant®. Methods: This prospective interventional case series was conducted on eyes with neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME). Stivant® was injected in three consecutive months and changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at baseline and monthly up to one month after the third injection. Results: Three hundred and eighty-five eyes with DME (234 eyes, 61%), nAMD (87 eyes, 22%), and macular edema secondary to RVO (64 eyes, 17%) were enrolled. The mean ± standard deviation age of the patients was 61.7 ± 7.20 years. The mean BCVA and CMT changed from 0.63 ± 0.3 to 0.51 ± 0.3 LogMAR (P = 0.12 ) and from 420.4 ± 47.3μm at baseline to 316.7 ± 50.6 μm (P < 0.001) in the DME group; from 0.79 ± 0.3 to 0.68 ± 0.3 LogMAR (P = 0.19) and from 376.1 ± 31.7 μm to 303 ± 31.3 μm (P = 0.019) in the nAMD group; and from 0.81 ± 0.4 to 0.63 ± 0.4 LogMAR (P = 0.05) and from 424.21 ± 18 μm to 303.4 ± 18.8 μm (P < 0.001) in the RVO group, respectively. Conclusion: Our limited experience showed that the intravitreal injection of Stivant® was well tolerated. Although the results of this case series showed relative improvement in CMT one month after the last injection of Stivant®, BCVA improvement was statistically significant only in the RVO group. This would be essential to design a randomized clinical trial to evaluate the non-inferiority of Stivant® in comparison to bevacizumab.

2019 ◽  
Author(s):  
Gaku Terauchi ◽  
Kei Shinoda ◽  
Hiroyuki Sakai ◽  
Makoto Kawashima ◽  
Soichi Matsumoto ◽  
...  

Abstract Background: To evaluate the retinal function before and soon after an intravitreal injection of an anti-vascular endothelial growth factor (anti-VEGF) agents. Methods: Seventy-nine eyes of 79 patients that were treated by an intravitreal injection of an anti-VEGF agent for age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion (RVO) with macular edema (ME) were studied. The RETeval® system was used to record 28 Hz flicker electroretinograms (ERGs) from the injected and non-injected eyes before (Phase 1, P1), within 2 hours after the injection (P2), and 2 to 24 hours after the injection (P3). Patients were grouped by disease or by the injected agent and compared. The significance of the changes in the implicit times and amplitudes was determined by t tests. Results: The amplitudes were not significantly different at the three phases. The implicit time of the injected eye was 31.2±3.2 msec at P1, and it was not significantly different at P2 (31.7±3.1 msec) but it was significantly longer at P3 (32.2±3.3 msec, P<0.01, ANOVA for both). The implicit time in the non-injected fellow eye was 30.5±3.3 msec at P1, and it was significantly longer at P2 (31.1±3.2 msec) and phase 3 (31.3±3.4 msec, P<0.01, ANOVA for both). Conclusions: The results indicate that an intravitreal anti-VEGF injection will increase the implicit times not only in the injected eye but also in the non-injected eye soon after the intravitreal injection.


2019 ◽  
Author(s):  
Gaku Terauchi ◽  
Kei Shinoda ◽  
Hiroyuki Sakai ◽  
Makoto Kawashima ◽  
Soichi Matsumoto ◽  
...  

Abstract Background: To evaluate the retinal function before and soon after an intravitreal injection of an anti-vascular endothelial growth factor (anti-VEGF) agents. Methods: Seventy-nine eyes of 79 patients that were treated by an intravitreal injection of an anti-VEGF agent for age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion (RVO) with macular edema (ME) were studied. The RETeval® system was used to record 28 Hz flicker electroretinograms (ERGs) from the injected and non-injected eyes before (Phase 1, P1), within 2 hours after the injection (P2), and 2 to 24 hours after the injection (P3). Patients were grouped by disease or by the injected agent and compared. The significance of the changes in the implicit times and amplitudes was determined by t tests. Results: The amplitudes were not significantly different at the three phases. The implicit time of the injected eye was 31.2±3.2 msec at P1, and it was not significantly different at P2 (31.7±3.1 msec) but it was significantly longer at P3 (32.2±3.3 msec, P<0.01, ANOVA for both). The implicit time in the non-injected fellow eye was 30.5±3.3 msec at P1, and it was significantly longer at P2 (31.1±3.2 msec) and phase 3 (31.3±3.4 msec, P<0.01, ANOVA for both). Conclusions: The results indicate that an intravitreal anti-VEGF injection will increase the implicit times not only in the injected eye but also in the non-injected eye soon after the intravitreal injection.


2019 ◽  
Author(s):  
Gaku Terauchi ◽  
Kei Shinoda ◽  
Hiroyuki Sakai ◽  
Makoto Kawashima ◽  
Soichi Matsumoto ◽  
...  

Abstract Background: To evaluate the retinal function before and after intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents in the injected and non-injected eyes. Methods: Seventy-nine eyes of 79 patients that were treated by an intravitreal injection of an anti-VEGF agent for age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion (RVO) with macular edema (ME) were studied. The RETeval® system was used to record 28 Hz flicker electroretinograms (ERGs) from both eyes before (phase 1), within 2 hours after the injection (phase 2), and 2 to 24 hours after the injection (phase 3). Patients were grouped by disease or by the injected agent and compared. The significance of the changes in the implicit times and amplitudes was determined by t tests. Results: The amplitudes were not significantly different among the groups. The implicit times were significantly longer or tended to be longer at phase 2 and 3 compared to phase 1 for each disease and for each injected agent in the injected and non-injected eyes. Conclusions: The results show that an intravitreal anti-VEGF injection will prolong the implicit times not only in the injected eye but also in the non-injected eye soon after the intravitreal injection. Trial registration: All of the patients gave a written informed consent and the study was conducted in accordance with the tenets of Declaration of Helsinki and approved by the Ethics Committee of the Teikyo University School of Medicine (study ID number: 14-122). Keywords: Aflibercept, age-related macular degeneration, electroretinogram, intravitreal injection, macular edema, ranibizumab, retinal vein occlusion, vascular endothelial growth factor.


2005 ◽  
Vol 15 (4) ◽  
pp. 462-464 ◽  
Author(s):  
J.B. Jonas ◽  
R. Degenring ◽  
U. Vossmerbauemer ◽  
B. Kamppeter

Purpose To evaluate the frequency of cataract surgery after intravitreal injection of high-dosage triamcinolone acetonide in elderly patients. Methods This clinical interventional case series study included 144 phakic eyes that consecutively received an intravitreal injection of about 20 mg triamcinolone acetonide for diffuse diabetic macular edema (n=42 eyes), exudative age-related macular degeneration (n=98), and branch retinal vein occlusion (n=4). Mean age was 72.3±8.9 years. Mean follow-up was 11.0±6.8 months (median, 8.8 months; range, 3 to 35.5 months). Reinjections were carried out in 12 (8.3%) eyes. Results Cataract surgery was performed in 20 (13.9%) eyes 17.4±9.1 months (median, 12.7 months; range, 8.0 to 35.5 months) after the first intravitreal injection. Out of the 20 eyes undergoing cataract surgery, 19 (95%) eyes had received one intravitreal injection, and 1 (5%) eye had received two previous injections. Conclusions In the elderly population of patients with exudative age-related macular degeneration, diffuse diabetic macular edema, or branch retinal vein occlusion, intravitreal high-dosage injection of triamcinolone acetonide leads to clinically significant cataract with eventual cataract surgery in about 15% to 20% of eyes within about 1 year after the intravitreal injection.


2021 ◽  
Vol 10 (15) ◽  
pp. 3281
Author(s):  
Carolina Arruabarrena ◽  
Mario Damiano Toro ◽  
Mehmet Onen ◽  
Boris E Malyugin ◽  
Robert Rejdak ◽  
...  

This is a retrospective, multicenter study of consecutive patients with nAMD scheduled for a visit and/or a treatment with an intravitreal injection (IVI) during the 3 months before lockdown in the Ophthalmology Departments of six centers of Europe.The study was conducted on 546 patients, of which 55.13% were females, almost 100% of the patients were White/Caucasian race, and 71.53% of the patients presented a type 1 macular neovascularization (NVM). A total of 62.82% of patients (343 patients) that were on scheduled clinic visits and/or intravitreal injection treatment during the 3 months before the quarantine did not attend either to visit or for treatment during the lockdown. The mean number of injections during the lockdown was significantly reduced. This was followed by a significant reduction in the mean best-corrected visual acuity (BCVA) between the 3 months before the lockdown (mean BCVA of 60.68 ± 19.77 letters) and 6 months after lockdown (mean BCVA of 56.98 ± 22.59 letters). Patients with better BCVA before the lockdown and the ones showing neovascular activity were more likely to attend their scheduled visits and/or IVI treatments. The COVID-19 pandemic and the lockdown have led to a decrease in the number of IVI treatments in patients with nAMD, evidencing a significant vision loss at 6 months.


2020 ◽  
Vol 36 (3) ◽  
Author(s):  
Hussain Ahmad Khaqan ◽  
Usman Imtiaz ◽  
Hasnain Muhammad Buksh ◽  
Hafiz Ateeq Ur Rehman ◽  
Raheela Naz

Purpose:  To study the safety and efficacy of intravitreal Ziv-Aflibercept vs. Bevacizumab for the management of edema caused by different retinal pathologies. Study Design:  Comparative interventional study. Place and Duration of Study:  Lahore General Hospital, Lahore, from July 2018 to June 2019. Material and Methods:  Patients with resistant, center involving macular edema due to diabetes, retinal vein occlusion and age related macular degeneration were recruited. Complete ocular examination was performed. All the patients were randomly grouped into two i.e. IVZ (intravitreal Ziv-Aflibercept) and IVB (intravitreal bevacizumab). Each eye underwent intravitreal injection of 0.05 ml of fresh filtered ziv-aflibercept (1.25 mg) or 0.05 ml of fresh filtered Bevacizumab. Outcome was measured in terms of variation in central macular thickness (CMT) and also best corrected visual acuity (BCVA) at 3 months. Results:  Total of 156 eyes of 136 patients completed whole duration of study and were included in the results. The mean baseline CMT was 510 μm (± 94 μm) in the IVB group and 493μm (±102 μm) in the IVZ group (P = 0.94). The mean baseline BCVA (log MAR) was 0.78 (Snellen's equivalent 6/36) in the IVZ and 0.70 (Snellen's equivalent 6/30) in the IVB group (P = 0.78). Central macular thickness was significantly reduced at 1st, 2nd and 3rd month in the IVZ group and IVB group (P < 0.001). Conclusion:  Intravitreal Ziv-Aflibercept is safe and more effective than Bevacizumab for the treatment of edema caused by diabetes mellitus, retinal vein occlusion and wet age related macular degeneration.


2013 ◽  
Vol 5 (1) ◽  
pp. 57-62 ◽  
Author(s):  
R Thapa ◽  
G Paudyal ◽  
AS Crandall ◽  
G Tabin

Introduction: Nepal has many mountains including the highest one in the world. People living in high altitude are often involved in climbing mountains. Objective: To explore the pattern of vitreo-retinal disorders at high altitude in Nepal. Materials and methods: Consecutive patients aged 40 years and older who presented at the micro-surgical eye camp at Lukla of Solukhumbu district (2,860 metres) were included. Detailed ocular and systemic histories and ocular examination including dilated fundus evaluation were done. Results: There were a total 81 patients with the mean age of 56.7 years (S.D 11.15). Females (51.9 %) outnumbered males. Sherpa comprised of 76.5 % followed by Rai (9.8 %). The main occupation was agriculture (51.9 %) followed by mountain trekking (28.4 %). Smokers comprised of 13.5 %. Hypertension was the predominant systemic problem (28 %). The best corrected visual acuity of 6/18 and better was found in 86.4 % of cases and less than 3/ 60 in 3.6 % of cases. Age-related macular degeneration (AMD) was found in 19.6 % of cases with a predominant mild AMD (16 %), hypertensive retinopathy in 12.2 %, with grade I hypertensive change in 8.6 %, retinal vein occlusion (RVO) in 7.1 % of cases and with a branch RVO in 4.9 %. Dilated and tortuous retinal vessels were present in 25.9 % of cases; out of this, 9.8 % of the cases had concurrent AMD and/or hypertensive retinopathy. Other retinal problems were macular hole (2.46 %), solar retinopathy (2.46 %) and choroidal tear (1.2 %). Conclusion: AMD, hypertensive retinopathy, and RVO are the main vitreo-retinal disorders besides the dilated and tortuous retinal vessels in people living at high altitude in Nepal. Nepal J Ophthalmol 2013; 5(9):57-62 DOI: http://dx.doi.org/10.3126/nepjoph.v5i1.7823


2015 ◽  
Vol 234 (1) ◽  
pp. 33-39 ◽  
Author(s):  
Wataru Matsumiya ◽  
Shigeru Honda ◽  
Keiko Otsuka ◽  
Akiko Miki ◽  
Takayuki Nagai ◽  
...  

Purpose: To compare the response to ranibizumab between patients with typical neovascular age-related macular degeneration (tAMD) and those with polypoidal choroidal vasculopathy (PCV), and to determine the predictors for the outcomes. Methods: Fifty-nine eyes from 59 consecutive patients (tAMD: 27 eyes, PCV: 32 eyes) were treated with three monthly ranibizumab injections followed by as-needed retreatment. Best-corrected visual acuity (BCVA) and morphological parameters were evaluated over 24 months of follow-up. Results: The mean BCVA in tAMD and PCV patients was significantly improved at 3 months (-0.22 and -0.09 logMAR units, respectively). The improvement in BCVA was sustained up to 24 months in tAMD (p = 0.01) but not in PCV patients. The significant predictor for good response to ranibizumab in tAMD patients was the improvement of BCVA at 3 months, whereas that in PCV patients was the anatomical resolution at 3 months. Conclusions: Ranibizumab is an effective therapy for tAMD and PCV over 24 months. The predictors for good outcome might be different between tAMD and PCV.


2020 ◽  
Vol 9 (8) ◽  
pp. 2360
Author(s):  
Yusuke Arai ◽  
Hidenori Takahashi ◽  
Satoru Inoda ◽  
Shinichi Sakamoto ◽  
Xue Tan ◽  
...  

Purpose: To assess the efficacy and safety of a modified treat-and-extend (mTAE) regimen of aflibercept for macular edema (ME) due to branch retinal vein occlusion (BRVO). Methods: This prospective multicentre intervention study evaluated 50 eyes of 50 patients enrolled from October 2016 to September 2017. The patients received intravitreal aflibercept (IVA) injections on an mTAE regimen for a total of 12 months. The main outcome measures were best-corrected visual acuity (BCVA) and central subfield thickness (CST) at 12 months. Results: The baseline BCVA and CST were 0.33 (0.27) and 488 (171) µm (mean (standard deviation)), respectively. The BCVA and CST were significantly improved at month 12 (0.067 (0.19) LogMAR and 295 (110) µm; both p < 0.0001, paired t-test). The mean number of clinic visits and IVA injections was 6.71 (1.41) and 4.26 (0.71), respectively. The time to first recurrence from the first injection was most frequently 3 months. Conclusion: The mTAE regimen of IVA injections for ME due to BRVO effectively improved BCVA and reduced CST, and thus might be an effective therapy to reduce the number of injections and visits.


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.


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