scholarly journals Switching to Ziv-aflibercept In Resistant Diabetic Macular Edema Non Responsive to Ranibizumab Injection

Author(s):  
Amin E. Nawar ◽  
Tamer Wasfy ◽  
Heba M. Shafik

Abstract Background: Diabetic macular edema (DME) is a leading cause of visual loss in diabetic patients and is managed using multiple anti-vascular endothelial growth factor (VEGF) agents such as bevacizumab, ranibizumab and aflibercept. The present study evaluates effectiveness of intravitreal injection of ziv-aflibercept in resistant diabetic macular edema.Methods: This is a prospective interventional study that was carried out on 59 eyes of 40 diabetic patients with diabetic macular edema resistant to three prior consecutive ranibizumab injections. On all patients, thorough ophthalmic evaluation including optical coherence tomography was performed. In patients with persistent intraretinal or subretinal fluid, ziv- aflibercept 1.25 mg (0.05 ml) was administered by intravitreal injection monthly during the 6month study period from June to December 2019.Results: The central macular thickness (CMT) decreased significantly from 395.08±129.9 um at baseline to 282.39±95.278, 245.36±79.861 and 201.17±54.042 after one, three and six months of treatment respectively (p < 0.001). Best corrected visual acuity (BCVA) in log MAR units was significantly improved from 0.95±0.21 to 0.51±0.23 after six months (p = 0.001). After treatment, negative correlations were detected between age, number of injections, duration of DM and level of glycated hemoglobin (HbA1C) and variation of both CMT and BCVA. The only significant predictor for low final CMT after six months of injection was the CMT after three months of injection (p = 0.001).Conclusion: Ziv-aflibercept is a highly effective and safe drug in cases of DME resistant to previous ranibizumab injections especially in low-income countries.This study was retrospectively registered at clinicaltrials.gov (ID: NCT04290195) on 26-2-2020

2018 ◽  
Vol 1 ◽  
pp. 2
Author(s):  
Cindy Ung ◽  
Kareem Moussa ◽  
Yoshihiro Yonekawa

Diabetic macular edema (DME) is the main cause of visual impairment in diabetic patients. Intravitreal anti-vascular endothelial growth factor (VEGF) therapy is considered the first-line treatment option in the management of DME with corticosteroids used as second-line therapy. The DRCR.net Protocol U study was a Phase II trial that sought to compare the combination of a steroid and anti-VEGF therapy to anti-VEGF monotherapy regarding visual acuity and anatomic outcomes. This review highlights the strengths, weaknesses, and clinical implications of this study.


2019 ◽  
Vol 30 (5) ◽  
pp. 1091-1098 ◽  
Author(s):  
Adrian Hernández Martínez ◽  
Ernesto Pereira Delgado ◽  
Guillermo Silva Silva ◽  
Luis Castellanos Mateos ◽  
José Lorente Pascual ◽  
...  

Purpose: To compare the results of early versus late switch to the dexamethasone intravitreal implant Ozurdex® in patients with diabetic macular edema who had a poor response to vascular endothelial growth factor inhibitors. Methods: Retrospective and single-center study conducted, in a real setting, on consecutive diabetic macular edema patients who were switch to an intravitreal dexamethasone implant after a poor response to anti-vascular endothelial growth factor treatment. Study sample was divided into two groups: (1) early-switch group, included those eyes who received three anti-vascular endothelial growth factor injections before switch and (2) late-switch group, included those eyes that received six or more anti-vascular endothelial growth factor injections before switch. The primary end-point was the difference in mean change in best-corrected visual acuity and in central subfoveal thickness. Results: A total of 69 (31 early-switch group and 38 late-switch group) eyes were included. In the early-switch group, median (25–75 quartile range) best-corrected visual acuity significantly increase from 0.2 (0.2–0.5) at baseline to 0.4 (0.3 –0.7) at month 24 (p = 0.0043). Whereas, in the late-switch group, best-corrected visual acuity did not increase (p = 0.8602). Central subfoveal thickness was significantly reduced in both early- and late-switch groups, p = 0.0002 and 0.0038, respectively. The proportion of eyes obtaining a central subfoveal thickness reduction ⩾ 10% was significantly greater in the early-switch group than in the late-switch group (71.0% vs 47.4%, respectively, p = 0.0498). Three (9.7%) and 10 (26.3%) eyes have developed ocular hypertension during the study in the early- and late-switch groups, respectively, p = 0.0816. Conclusion: Early switch to Ozurdex in patients who did not adequately respond to anti-vascular endothelial growth factor therapy provided better functional and anatomical outcomes.


2021 ◽  
Author(s):  
Jing Wu ◽  
Clive Adams ◽  
Xiaoning He ◽  
Fang Qi ◽  
Jun Xia

Abstract Background: Different network meta-analyses (NMAs) on the same topic result in differences in findings. In this review we investigated network meta-analyses comparing ranibizumab with aflibercept for diabetic macular edema in the hope of illuminating why the differences in findings occurred.Findings: For the binary outcome of best corrected visual acuity, different reviews all agreed on their being no clear difference between the two treatments; while continuous outcomes all favour aflibercept over ranibizumab. We discussed four points of particular concern that are illustrated by five similar NMAs, including: network differences, PICO differences, different data from the same measures of effect, differences in what is truly significant.Conclusions: Closer inspection of each of these reviews shows how the methods, including the searches and analyses all differ but the findings, although presented differently and sometimes interpreted differently, were similar.


2016 ◽  
Vol 2016 ◽  
pp. 1-17 ◽  
Author(s):  
Pedro Romero-Aroca ◽  
Marc Baget-Bernaldiz ◽  
Alicia Pareja-Rios ◽  
Maribel Lopez-Galvez ◽  
Raul Navarro-Gil ◽  
...  

Diabetic macular edema (DME) can cause blindness in diabetic patients suffering from diabetic retinopathy (DR). DM parameters controls (glycemia, arterial tension, and lipids) are the gold standard for preventing DR and DME. Although the vascular endothelial growth factor (VEGF) is known to play a role in the development of DME, the pathological processes leading to the onset of this disease are highly complex and the exact sequence in which they occur is still not completely understood. Angiogenesis and inflammation have been shown to be involved in the pathogenesis of this disease. However, it still remains to be clarified whether angiogenesis following VEGF overexpression is a cause or a consequence of inflammation. This paper provides a review of the data currently available, focusing on VEGF, angiogenesis, and inflammation. Our analysis suggests that angiogenesis and inflammation act interdependently during the development of DME. Knowledge of DME etiology seems to be important in treatments with anti-VEGF or anti-inflammatory drugs. Current diagnostic techniques do not permit us to differentiate between both etiologies. In the future, diagnosing the physiopathology of each patient with DME will help us to select the most effective drug.


2015 ◽  
Vol 6 (1) ◽  
pp. 44-50 ◽  
Author(s):  
Joel Hanhart ◽  
Itay Chowers

Background/Aims: Bevacizumab and ranibizumab are routinely used to treat diabetic macular edema (DME). We aim to evaluate the usefulness of switching to ranibizumab therapy following bevacizumab treatment failure in eyes with DME. Methods: We performed a retrospective analysis of a consecutive group of patients with DME who received ranibizumab injections following the failure of bevacizumab injections. The injections were delivered following a pro re nata protocol every 4-6 weeks. The data collected included demographics, systemic and ophthalmic findings, as well as the central subfield thickness according to spectral-domain OCT. Results: Eight eyes (5 patients) were included in the study. The median number of bevacizumab injections prior to the switch to ranibizumab was 4, and the median number of ranibizumab injections during the study was 2. The mean follow-up period was 541 ± 258 days. The mean central retinal thickness (CRT) (±SEM) was 539 ± 75 μm before the initiation of bevacizumab treatment, and 524 ± 43 μm after the last bevacizumab injection (p = 0.7). It reduced to 325 ± 26 μm following the ranibizumab injections (p = 0.0063). The best-corrected visual acuity (BCVA) improved in 4 eyes and remained stable in 4 eyes following the ranibizumab injections. Conclusion: A ranibizumab therapy was effective in reducing the CRT in eyes that failed bevacizumab therapy. A BCVA improvement can also occur in these eyes. Switching between anti-vascular endothelial growth factor compounds may be beneficial in eyes with DME.


2021 ◽  
pp. 112067212098294
Author(s):  
Ahmed Mohammed Elbarky

Introduction: To evaluate 12-month outcomes following fluocinolone acetonide (FAc 0.2 μg/day) implant in pseudophakic patients with diabetic macular edema (DME) that persists or recurs despite previous treatment with anti-vascular endothelial growth factors (anti-VEGF) and dexamethasone implant (DEX) in a UAE population. Methods: A retrospective, observational, single-center, 12-month audit study, where 22 pseudophakic eyes (22 patients) with DME were treated with the FAc intravitreal implant according to licensed UAE indications. Outcome measurements at baseline and at months 1, 3, 6, and 12 included best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results: Post-FAc implantation, mean BCVA significantly improved at 1, 3, and 12 months (+10.4 ± 16.1, +22.8 ± 13.6, and +25.5 ± 13.0 letters, respectively; p < 0.0001), with 86% of eyes gaining ⩾15 letters at month 12. Similarly, CMT reduced significantly at month 1, and stabilized thereafter at months 3–12 (−171.5 ± 72.5 µm, −240.9 ± 74.2 µm, and −246.2 ± 93.4 µm, respectively; p < 0.0001). By month 12, 64% ( n = 14/22) of eyes had a CMT below 300 µm. Only 1 eye had an IOP ⩾ 21 mmHg at baseline and month 12. Five eyes required IOP lowering drops and 1 required IOP-lowering surgical intervention. Conclusion: In pseudophakic patients with DME FAc implant provide a substantial functional and anatomical benefits for up to 12 months.


2018 ◽  
Vol 11 (4) ◽  
pp. 51-66
Author(s):  
Fedor E. Shadrichev ◽  
Nyurguyana N. Grigor'eva ◽  
Elizaveta S. Rozhdestvenskaya

Diabetic retinopathy remains one of the greatest challenges for healthcare system worldwide despite the fact that the incidence of visual acuity impairment in diabetic population has decreased due to examination quality improvement and dynamic observation of patients. Visual acuity impairment in diabetic patients is often related to diabetic macular edema. Until recently, laser photocoagulation of the retina was regarded as gold standard for diabetic macular edema treatment. Laser photocoagulation of the retina provides visual acuity stabilization rather than improvement. Since early 2000s, pharmacological approach to this severe disease has been established. As vascular endothelial growth factor (VEGF) is one of the crucial factors involved in the pathogenesis of diabetic retinal disorders, VEGF inhibitors are now recognized as a treatment of choice for diabetic macular edema. This article considers results of different clinical trials investigating anti-VEGF therapy efficacy in DME treatment.


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