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1.
PHACOEMULSIFICATION CATARACT SURGERY WITH PROPHYLACTIC INTRAVITREAL BEVACIZUMAB FOR PATIENTS WITH COEXISTING DIABETIC RETINOPATHY: A Meta-Analysis.
Feng, Y, Zhu, S, Skiadaresi, E, McAlinden, C, Tu, R, Gao, R, Stephens, JW, Wang, Q, Huang, J
Retina (Philadelphia, Pa.). 2019;(9):1720-1731
Abstract
PURPOSE To evaluate the clinical effectiveness of intravitreal bevacizumab (IVB) injection combined with cataract surgery in the treatment of patients with cataract and coexisting diabetic retinopathy (DR). METHODS Pertinent comparative studies were identified through systemic searches of PubMed, EMBASE, and the Cochrane Controlled Trials Register up to March 1, 2016. Outcome measures included corrected distance vision acuity, central macular thickness, and progression of DR and maculopathy. A meta-analysis was performed using RevMan (Cochrane Collaboration, Oxford, United Kingdom). RESULTS Six studies describing a total of 283 eyes were identified. The meta-analysis results showed that corrected distance vision acuity measured at 1 month and 3 months after cataract surgery was significantly better in the IVB groups than in the control groups (P < 0.00001 and P = 0.01), whereas the corrected distance vision acuity at 6 months did not vary significantly between the 2 groups (P = 0.24). Similarly, the central macular thickness at 1, 3, and 6 months after surgery was significantly thinner in the IVB groups than in the control groups (P = 0.01, P = 0.0004, and P = 0.01, respectively). At 6 months, the progression of postoperative DR and maculopathy occurred more frequently in the control group than in the IVB group (P = 0.0001 and P < 0.0001, respectively). CONCLUSION Our meta-analysis indicates that cataract surgery combined with IVB seems to be an effective treatment in patients with coexisting DR in the short term (up to 6 months). More randomized, prospective, and large-sample-sized trials are needed to evaluate the long-term effects of IVB at the time of cataract surgery in patients with DR.
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2.
Prospective randomised clinical trial of intravitreal bevacizumab versus triamcinolone in eyes with diabetic macular oedema undergoing cataract surgery: 6-month results.
Kandasamy, R, Constantinou, M, Rogers, SL, Sandhu, SS, Wickremasinghe, S, Al-Qureshi, S, Lim, LL
The British journal of ophthalmology. 2019;(12):1753-1758
Abstract
AIM: To report the 6-month results of a clinical trial that compared intravitreous bevacizumab (BVB) 1.25 mg versus triamcinolone acetonide (TA) 4 mg when administered as an adjunct during cataract surgery to patients with diabetic macular oedema (DMO). METHODS Prospective, double-masked, single-centre (Royal Victorian Eye and Ear Hospital, Melbourne) clinical trial. Patients with visually significant cataract and centre-involving DMO (either current or prior) were randomised (1: 1) to receive either intravitreous BVB 1.25 mg or TA 4 mg at the time of cataract surgery and if required at review. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to the 6-month time point of this 12-month study. RESULTS 61 eyes of 58 patients were enrolled. At baseline, both groups were similar in terms of BCVA and CMT (p>0.2). At 6 months, there was no significant difference in vision between the groups, with mean letter gain of +21.4 (95% CI +14.5 to +28.4) in the TA group and +17.3 (95% CI +12.1 to +22.6) in the BVB group (p=0.35). The TA group had a significant sustained anatomical improvement at 6 months, with a reduction in CMT (-51.4 µm; 95% CI -98.2 to -4.7) compared with thickening in the BVB group (+15.6 µm; 95% CI -26.4 to +57.7, p=0.04). CONCLUSIONS When given as an adjunct to cataract surgery, both TA and BVB improved visual outcomes at 6 months postoperatively. However, only TA resulted in sustained improvement in CMT, with the majority not requiring any further treatment postoperatively.
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3.
Correlation of Macular Thickness and Visual Acuity in DME Treated by Two Doses of Intravitreal Ziv-Aflibercept Versus Bevacizumab: Analysis of a Randomized, Three-Armed Clinical Trial.
Jabbarpoor Bonyadi, MH, Baghi, A, Ramezani, A, Yaseri, M, Soheilian, M
Ophthalmic surgery, lasers & imaging retina. 2019;(11):684-690
Abstract
BACKGROUND AND OBJECTIVE To report the correlation of central macular thickness (CMT) and best-corrected visual acuity (BCVA) after 1-year treatment by two doses (2.5 mg or 1.25 mg) of intravitreal ziv-aflibercept (IVZ) versus bevacizumab (IVB) in eyes with diabetic macular edema (DME). PATIENTS AND METHODS In this study, the correlation of CMT and BCVA changes of the eyes enrolled in a previous clinical trial of 123 eyes were re-evaluated. The correlation of BCVA and CMT changes at each visit was evaluated in the three study arms individually. Then, the eyes in each of the arms were classified at each follow-up visit into three subgroups based on their CMT changes related to the baseline CMT: CMT decrease of 30% or more of baseline CMT, between 10% to 29% of baseline CMT, and less than 9% of baseline CMT or CMT increase. RESULTS BCVA and CMT changes were correlated significantly (P < .05) in all and in half of the follow-up visits, respectively, in the eyes treated by IVZ 1.25 mg and IVB (r = 0.554 and r = 0.617 at 1 year, respectively). Nevertheless, such a significant correlation was not detected in the eyes treated by IVZ 2.5 mg in any of the follow-up visits (r = 0.202 at 1 year; P = .259). In the IVZ 2.5 mg group, BCVA improvement was observed in all subgroups with each level of CMT reductions. CONCLUSION Ziv-aflibercept 2.5 mg might have a beneficial effect on DME beyond thickness reduction. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:684-690.].
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4.
Visual Outcomes of Pars Plana Vitrectomy Alone or with Intravitreal Bevacizumab in Patients of Diabetic Vitreous Haemorrhage.
Haseeb, U, Aziz-Ur-Rehman, , Haseeb, M
Journal of the College of Physicians and Surgeons--Pakistan : JCPSP. 2019;(8):728-731
Abstract
OBJECTIVE To evaluate the visual outcomes of pars plana vitrectomy (PPV) alone or with intravitreal bevacizumab in patients of diabetic vitreous haemorrhage. STUDY DESIGN A quasi-experimental study. PLACE AND DURATION OF STUDY Al-Ibrahim Eye Hospital, Malir, Karachi, from March to November 2018. METHODOLOGY Patients between 40-70 years of age, irrespective of gender with non-resolving dense diabetic vitreous haemorrhage were divided into two groups. Group A received injection bevacizumab 7 days before PPV surgery. Group B received no preoperative injection. Log Mar chart was used for documenting postoperative vision. All patients completed their 6 months follow-up. SPSS was used to analyse the data. RESULTS Best corrected visual acuity (BCVA) was documented as improved, same, or worse. In Group A, 21 (70%) patients had improved VA; whereas, in Group B, 17 (56.6%) patients showed improved visual acuity postoperatively. Patients were examined at four weeks, three months, and six months, respectively for recurrent vitreous haemorrhage. In Group A, 25 (83.3%) patients had no vitreous haemorrhage up to six months, whereas, in Group B, 13 (43.3%) patients had no vitreous haemorrhage up to six months with p-value of 0.021. CONCLUSION Anti VEGF injection bevacizumab before PPV in patients with non-resolving diabetic vitreous haemorrhage is good to get better results in terms of BCVA, as well as reduce the incidence of recurrent vitreous haemorrhage.
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5.
Effect of prior glaucoma surgery on intraocular pressure immediately after anti-vascular endothelial growth factor injection.
Lam, J, Luttrell, I, Ding, L, Rezaei, K, Chao, JR, Chee, Y, Olmos De Koo, LC, Wen, JC
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2019;(11):2489-2494
Abstract
BACKGROUND To characterize how prior incisional glaucoma surgery affects the intraocular pressure (IOP) elevation immediately following intravitreal anti-VEGF injections (IVI). METHODS Single institution, experimental study. Patients with a history of incisional glaucoma surgery who were receiving anti-VEGF injections were recruited as well as control eyes. Pre- and post-injection IOP measurements were compared as well as time to recovery to within 5 and 10 mmHg of baseline IOP. RESULTS Ten eyes with a history of glaucoma surgery and 29 control eyes receiving anti-VEGF injections were included. The most common indication for intravitreal anti-VEGF injection was proliferative diabetic retinopathy in both surgical and control eyes (50% vs 45%, p = 1.00). Post-injection IOP was significantly decreased compared to baseline IOP after anti-VEGF injection in surgical versus control eyes (26.5 ± 8.9 mmHg vs 44.2 ± 8.5 mmHg, respectively, p < 0.001). The mean change in IOP following intravitreal anti-VEGF injection was lower in surgical eyes (10.7 ± 6.6 mmHg vs 28.6 ± 8.3 mmHg, p < 0.001). The mean time for the IOP to return to within 10 mmHg of pre-injection IOP was less in surgical eyes (5.2 ± 4.1 min vs 13.3 ± 7.6 min, p = 0.002). CONCLUSIONS Eyes with prior incisional glaucoma surgery demonstrated a significantly lower post-injection IOP elevation and a faster recovery to within 10 mmHg of their pre-injection IOP. Incisional glaucoma surgery may be considered for patients where the attenuation of post-injection IOP elevation is needed and other less invasive measures have failed.
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6.
Phase II trial of ponatinib in patients with bevacizumab-refractory glioblastoma.
Lee, EQ, Muzikansky, A, Duda, DG, Gaffey, S, Dietrich, J, Nayak, L, Chukwueke, UN, Beroukhim, R, Doherty, L, Laub, CK, et al
Cancer medicine. 2019;(13):5988-5994
Abstract
BACKGROUND Responses to bevacizumab in glioblastoma (GBM) are not durable. Plasma levels of basic fibroblast growth factor (bFGF) increase at the time of tumor progression. By targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor, Src, and FGF receptor pathways, ponatinib may potentially help to overcome some of the putative mechanisms of adaptive resistance. METHODS We performed a phase II trial of ponatinib in patients with bevacizumab-refractory GBM and variants. Adult patients with Karnofsky performance score (KPS) ≥60, measurable disease, and normal organ and marrow function received 45 mg ponatinib daily. No limit on the number of prior therapies but only one prior bevacizumab-containing regimen was allowed. Primary endpoint was 3-month progression-free survival. Plasma biomarkers of angiogenesis and inflammation were evaluated before and after treatment. RESULTS The study closed after the first stage. Fifteen patients enrolled: median age 61 [27-74]; median KPS 80 [70-90]; median number of prior relapses 2 [2-4]. Three-month progression-free survival rate was 0, median overall survival was 98 days [95% CI 56, 257], and median PFS was 28 days [95% CI 27, 30]. No responses were seen. The most common grade ≥3 adverse events included fatigue (n = 3), hypertension (2), and lipase elevation (2). Ponatinib treatment significantly increased plasma VEGF, soluble (s)VEGFR1, sVEGFR2, sTIE2, interferon gamma (IFNγ), tumor necrosis factor alpha (TNF-α), interleukin (IL)-6, IL-8, and IL-10 and decreased sVEGFR2. CONCLUSIONS Ponatinib was associated with minimal activity in bevacizumab-refractory GBM patients. Circulating biomarker data confirmed pharmacodynamic changes and suggested that resistance to ponatinib may be related to an increase in inflammatory cytokines.
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7.
Ziv-aflibercept versus bevacizumab administration prior to diabetic vitrectomy: a randomised and controlled trial.
Aleman, I, Castillo Velazquez, J, Rush, SW, Rush, RB
The British journal of ophthalmology. 2019;(12):1740-1746
Abstract
PURPOSE To compare the effectiveness of intravitreal ziv-aflibercept (IVZ) to intravitreal bevacizumab (IVB) administered preoperatively to patients undergoing pars plana vitrectomy (PPV) for severe manifestations of proliferative diabetic retinopathy (PDR). DESIGN Randomised clinical trial (RCT). METHODS Two hundred and six patients with PDR-related complications requiring PPV were randomised into one of two treatment groups: Group A received IVZ (1.25 mg/0.05 mL) 1-10 days before PPV, while Group B received IVB (1.25 mg/0.05 mL) 1-10 days before PPV. The primary outcome was best-corrected visual acuity (BCVA) at 6 months follow-up. Secondary outcome measures were perioperative tractional retinal detachment (TRD) rates, surgical times, intraoperative and postoperative complications and incidence of unplanned PPV during the 6 month study interval. RESULTS One hundred and seventy three subjects underwent PPV and completed the 6-month follow-up interval. Group A subjects had better BCVA at 6 months (p=0.0035), shorter surgical times (p=0.0013) and were less likely to have a recurrence of vitreous haemorrhaging in the postoperative period (p=0.0101) when compared with subjects in Group B. There were no significant differences among the treatment groups with regards to baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV during the 6 month study interval. CONCLUSIONS This RCT demonstrated better final visual outcomes, shorter operating times and less vitreous haemorrhage recurrences in the postoperative period when subjects received IVZ compared to IVB prior to PPV for the treatment of PDR-related complications.
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8.
Development of New Proliferative Diabetic Retinopathy in the BEVORDEX Trial.
Mehta, H, Lim, LL, Nguyen, V, Qatarneh, D, Wickremasinghe, SS, Hodgson, LAB, Quin, GJ, McAllister, IL, Gillies, MC, Fraser-Bell, S
Ophthalmology. Retina. 2019;(3):286-287
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9.
Preoperative intravitreal bevacizumab for proliferative diabetic retinopathy patients undergoing vitrectomy - First update.
Pérez-Argandoña, E, Verdaguer, J, Zacharías, S, González, R
Medwave. 2019;(1):e7512
Abstract
UPDATE This Living FRISBEE (Living FRIendly Summary of the Body of Evidence using Epistemonikos) is an update of the summary published in December 2014. INTRODUCTION Proliferative diabetic retinopathy can cause severe vision loss and even blindness if left untreated. Vitrectomy is often required in the treatment of more severe cases. Preoperative administration of bevacizumab, a humanized anti-vascular endothelial growth factor would improve intraoperative variables that facilitate surgery and improve postoperative course. METHODS We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS We identified five systematic reviews including 16 studies overall, of which 14 were randomized trials. We concluded the preoperative use of intravitreal bevacizumab reduces the rate of vitreous hemorrhage in the early postoperative period, and probably also in the late postoperative period, but its effect on visual acuity is not clear. Furthermore, it probably decreases the surgical time and may decrease the incidence of iatrogenic retinal breaks. Although we are uncertain whether preoperative bevacizumab decreases intraoperative bleeding, it may reduce the need for endodiathermy.
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10.
Comparisons Between PET With 11C-Methyl-L-Methionine and Arterial Spin Labeling Perfusion Imaging in Recurrent Glioblastomas Treated With Bevacizumab.
Beppu, T, Sato, Y, Sasaki, T, Terasaki, K, Yamashita, F, Sasaki, M, Ogasawara, K
Clinical nuclear medicine. 2019;(3):186-193
Abstract
PURPOSE The aim of this study was to clarify whether arterial spin labeling (ASL) perfusion imaging can assess biological effects from bevacizumab (BEV) therapy as reliably as PET with C-methyl-L-methionine (C-met-PET). MATERIALS AND METHODS Twenty-four patients with recurrent glioblastoma were examined using both ASL and C-met-PET before and 4 and 8 weeks after starting BEV treatment. Tumor-to-normal brain (T/N) ratios, fluctuations in T/N ratio, and tumor volumes were compared between ASL and C-met-PET. Accuracy of predicting patient with long progression-free survival (PFS) was assessed for T/N ratios and fluctuations for ASL and C-met-PET in each phase and in each period using receiver operating characteristic curves. Between 2 groups of patients assigned by cutoff values from receiver operating characteristic curves, PFS was compared in each phase or in each period. RESULTS T/N ratios, fluctuations in ratio, and tumor volumes correlated significantly between ASL and C-met-PET at all time points and all periods. Arterial spin labeling was eligible as a predictor for long PFS only in assessment of fluctuations in T/N ratio. However, the most accurate predictors for long PFS were T/N ratio from C-met-PET at 8 weeks and the fluctuation from baseline to 4 weeks in T/N ratio from C-met-PET. CONCLUSIONS Blood flows on ASL correlated with accumulations of C-met on PET in recurrent glioblastoma under BEV treatment. Although C-met-PET offered superior accuracy for predicting patients with long PFS from time points, ASL offered reliable prediction of long PFS, provided that fluctuations in T/N ratio between consecutive scans are assessed.