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Prospective study of aflibercept for the treatment of persistent macular oedema secondary to retinal vein occlusions in eyes not responsive to long-term treatment with bevacizumab or ranibizumab.
Spooner, K, Fraser-Bell, S, Hong, T, Chang, A
Clinical & experimental ophthalmology. 2020;(1):53-60
Abstract
IMPORTANCE To examine the effect of switching from intravitreal bevacizumab or ranibizumab to aflibercept in eyes with persistent macular oedema due to retinal vein occlusion (RVO). BACKGROUND We report the results of a prospective interventional study on the effect of aflibercept 2 mg in eyes with persistent macular oedema after long-term treatment with bevacizumab or ranibizumab. DESIGN Non-randomized, prospective clinical trial. PARTICIPANTS Eighteen eyes of eighteen patients were included. METHODS Eyes with persistent macular oedema despite a minimum of four previous intravitreal bevacizumab/ranibizumab injections were recruited into this 48-week trial. Three loading doses of intravitreal aflibercept were administered every 4-weeks, thereafter every 8-weeks until week 48. MAIN OUTCOME MEASURES Mean change from baseline in best corrected visual acuity (BCVA) as measured by early treatment diabetic retinopathy score (ETDRS) and central macular thickness (CMT) as measured by spectral domain optical coherence tomography (SD-OCT) at 48 weeks. RESULTS Patients had received a mean of 40.0 ± 17.8 bevacizumab/ranibizumab intravitreal injections prior to switching to aflibercept. The mean number of previous injections administered in the 12-months preceding entry into the study was 10.2 ± 2.4. Mean vision change at week 48 was +21.1 ± 5.1 ETDRS letters in the BRVO group and +18.8 ± 5.9 letters at in the CRVO group (P < .001 for both groups). Mean decrease in CMT was 87.6 ± 48.8 μm and 191.0 ± 128.3 μm, in the BRVO and CRVO groups, respectively (P < .001). Using linear regression analyses, a higher number of previous intravitreal ranibizumab/bevacizumab injections and thicker pre-switch CMT were correlated with greater visual gains. CONCLUSION AND RELEVANCE Switching to aflibercept from bevacizumab or ranibizumab in eyes with persistent macular oedema due to RVO can lead to functional and anatomical improvement. This effect was more obvious in eyes with a greater CMT prior to the switch.
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Technical considerations in the development of circulating peptides as pharmacodynamic biomarkers for angiogenesis inhibitors.
Thomeas, V, Chow, S, Gutierrez, JO, Karovic, S, Wroblewski, K, Kistner-Griffin, E, Karrison, TG, Maitland, ML
Journal of clinical pharmacology. 2014;(6):682-7
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Abstract
To determine the biological reproducibility and estimate relevant covariates for candidate circulating biomarkers of angiogenesis, we conducted 3 sub-studies with ≤15 subjects each. In study 1, 6 healthy subjects provided 13 blood samples across 14-24 days. In study 2, 15 advanced solid tumor patients provided single blood samples before, and approximately 8 and 40 days after sorafenib treatment. In study 3, 4 healthy subjects provided blood samples on 3 occasions over 14 days, processed simultaneously in 2 different laboratories at a single institution. Vascular endothelial growth factor (VEGFA), soluble VEGF receptor-2 (sVEGFR2), and angiopoietin-2 (Ang2) concentrations in plasma and serum were determined by standard immunoassays. Ang2 and sVEGFR2 demonstrated low variance within and high variance across individuals reflected by the high intraclass correlation coefficient (for Ang2: 0.86 for plasma, 0.89 for serum; for sVEGFR2: 0.91 for plasma, 0.87 for serum). Repeated measures linear modeling from 15 patients demonstrated increased Ang2 (P ≤ 0.05) and decreased sVEGFR2 (P ≤ 0.05) after exposure to sorafenib. VEGFA had high intraindividual variance, and study 3 demonstrated the laboratory to have significant effects on plasma measurements (P ≤ 0.05). The biological reproducibility of sVEGFR2 and Ang2 support further use of these markers in studies of vasculature-targeted therapeutics.
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Intravitreal bevacizumab for the treatment of nonarteritic anterior ischemic optic neuropathy: a prospective trial.
Rootman, DB, Gill, HS, Margolin, EA
Eye (London, England). 2013;(4):538-44
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Abstract
PURPOSE There is currently no accepted treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION). One new therapeutic approach involves decreasing optic nerve edema with intravitreal bevacizumab in order to resolve a proposed compartment syndrome. METHODS In this non-randomized controlled clinical trial, 1.25 mg intravitreal bevacizumab was compared with natural history. Patients were examined at baseline, 1, 3, and 6 months with a full neuro-ophthalmic exam, automated perimetry, and optic nerve optical coherence tomography (OCT) measurements. The primary outcome measure was change in mean deviation on Humphrey visual field testing. Secondary outcome measures were change in visual acuity and optic nerve OCT thickness. Incidence and type of complications were also recorded. RESULTS Twenty-five patients were enrolled (17 treatment and 8 control). There was no significant effect of treatment on the primary outcome measure of mean deviation score (P=0.4). There was similarly no effect of group assignment on the secondary outcome measures of change in mean Early Treatment Diabetic Retinopathy Study letters (P=0.33) or nerve fiber layer thickness on OCT (P=0.11). In the bevacizumab group, there was one case of a corneal abrasion and two cases of recurrent NAION. No other complications were noted. CONCLUSIONS We found no difference between bevacizumab and natural history for change in visual field, visual acuity, or optic nerve OCT thickness. Based on the current evidence we would not recommend the use of intravitreal bevacizumab to treat patients with the new onset of NAION.
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Bevacizumab (Avastin) as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy: a prospective case series.
Abdelhakim, MA, Macky, TA, Mansour, KA, Mortada, HA
Ophthalmic research. 2011;(1):23-30
Abstract
PURPOSE To evaluate the role of preoperative intravitreal bevacizumab as an adjunct to vitrectomy in diabetic eye disease. METHODS Twenty eyes of 18 patients were recruited and underwent a single intravitreal injection of bevacizumab 1.25 mg 1 week prior to vitrectomy. Fundus fluorescein angiography (FFA) was done before and 1 week after injections. Best corrected visual acuity (BCVA) and ophthalmic evaluation were done before, 1 week after injections, 1 day, 1 week and monthly for 3 months after vitrectomy. RESULTS The mean age was 47.7 ± 10.39 years. The male:female ratio was 2:3. Mean preinjection BCVA (logMAR) was 1.460 ± 0.439. FFA showed a dramatic reduction in dye leakage 1 week after injection. Intraoperative bleedings were minimal in most cases (85%, n = 17). Postoperatively, 16 patients had no bleeding (80%), 4 had minimal bleeding (20%), and 1 had recurrent fibrovascular proliferation (5%). The mean BCVA on day 1, week 1, months 2 and 3 after surgery were 1.645 ± 0.422, 1.300 ± 0.413, 1.065 ± 0.538 and 1.065 ± 0.538 logMAR, respectively (p = 0.078, 0.123, 0.002 and 0.002, respectively). CONCLUSION Bevacizumab administered prior to vitrectomy was well tolerated and was particularly useful during surgery.
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Metastatic renal carcinoma: evaluation of antiangiogenic therapy with dynamic contrast-enhanced CT.
Fournier, LS, Oudard, S, Thiam, R, Trinquart, L, Banu, E, Medioni, J, Balvay, D, Chatellier, G, Frija, G, Cuenod, CA
Radiology. 2010;(2):511-8
Abstract
PURPOSE To determine whether tumor perfusion parameters assessed by using dynamic contrast material-enhanced computed tomography (CT) could help predict and detect response in patients receiving antiangiogenic therapy for metastatic renal cell carcinoma. MATERIALS AND METHODS Institutional ethics committee approval and informed consent were obtained. In two phase-III trials involving 51 patients with metastatic renal cell carcinoma (38 men, 13 women; age range, 30-80 years) receiving antiangiogenic drugs (sorafenib [n = 10], sunitinib [n = 22]), a placebo (n = 12), or interferon alfa (n = 7), serial dynamic contrast-enhanced CT was performed, during 90 seconds before and after injection of 80 mL of iobitridol. Perfusion parameters of a target metastatic tumor (tumor blood flow [TBF], tumor blood volume [TBV], mean transit time, and vascular permeability-surface area product) were calculated. Values before and after treatment were compared by using a Wilcoxon signed rank test, and relative changes in groups were compared by using the Wilcoxon rank sum test. Results were compared with Response Evaluation Criteria in Solid Tumors response and with progression-free and overall survival by using Kaplan-Meier curves. RESULTS Among patients receiving antiangiogenic drugs, baseline perfusion parameters were higher in responders than in stable patients (TBF = 245.3 vs 119.5 mL/min/100 mL, P = .04; TBV = 15.5 vs 8.2 mL/100 mL, P = .02) but were not significantly predictive of survival. After the first cycle of treatment, there was a significant decrease in TBF (162.5 vs 76.7 mL/min/100 mL, P = .0002) and TBV (9.1 vs 3.9 mL/100 mL, P < .0001) in patients receiving antiangiogenic treatment. CONCLUSION Renal carcinoma perfusion parameters determined with dynamic contrast-enhanced CT can help predict biologic response to antiangiogenic drugs before beginning therapy and help detect an effect after a single cycle of treatment.
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[Bevacizumab for the treatment of macular edema secondary to retinal vein occlusion].
Schaal, KB, Höh, AE, Scheuerle, A, Schütt, F, Dithmar, S
Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft. 2007;(4):285-9
Abstract
BACKGROUND Retinal vein occlusion often leads to macular edema as a result of an elevated level of intravitreal VEGF. We report on the anatomic and functional results after intravitreal bevacizumab injections in patients with retinal vein occlusion. METHODS In a prospective study, 18 patients with central, and 22 patients with branch retinal vein occlusion, all of whom had persistent macular edema (>300 microm) received 2.5 mg intravitreal bevacizumab. ETDRS visual acuity, ophthalmic examination and stratus OCT were performed at baseline, 1 week after injection and then monthly. Further injections were given every 6 weeks in patients with persistent or recurring macular edema. RESULTS The findings did not deteriorate in any of the 40 patients. The injections (mean of 2.6+/-1.4 injections/patient) were very well tolerated in all cases during a mean follow-up of 23+/-13 weeks. On the last visit, 73.3% of patients with central retinal vein occlusion and 76.5% of those with branch retinal vein occlusion were found to have significantly improved visual acuity (by at least 3 lines). Mean central retinal thickness had decreased from 921+/-264 to 239+/-66.2 microm in patients with central retinal vein occlusion, and from 678+/-221 to 236+/-78 microm in patients with branch retinal vein occlusion. CONCLUSIONS Neither intraocular nor systemic side-effects were observed in this study after repeated intravitreal injections of 2.5 mg bevacizumab. Current results suggest that intravitreal anti-VEGF therapy is a promising option in macular edema secondary to retinal vein occlusion.