scholarly journals On the appropriate interpretation of evidence: the example of anti-vascular endothelial growth factor for diabetic macular edema

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.

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.


2019 ◽  
Vol 30 (6) ◽  
pp. 1461-1466
Author(s):  
Maurizio Battaglia Parodi ◽  
Francesco Romano ◽  
Alessandro Arrigo ◽  
Raffaele Sacchi ◽  
Gianluca Scanzi ◽  
...  

Purpose: To study the real-life outcomes of intravitreal anti–vascular endothelial growth factor treatment in patients affected by age-related macular degeneration and diabetic macular edema in an Italian tertiary referral hospital over a 2-year follow-up. Methods: Patients with confirmed diagnosis of age-related macular degeneration or diabetic macular edema and 2 years of follow-up were retrospectively analyzed. They underwent a loading dose of three monthly anti–vascular endothelial growth factor injections, with re-treatment performed following a “pro-re-nata” regimen. Best-corrected visual acuity and central retinal thickness were collected and statistically analyzed. Results: In total, 167 diabetic macular edema eyes and 108 age-related macular degeneration eyes were included. Mean age was 63.4 ± 11.8 years for diabetic macular edema and 75.6 ± 8.4 years for age-related macular degeneration. For diabetic macular edema patients, mean number of injections was 5.0 ± 1.7 at 1 year and 2.8 ± 1.8 at 2 years. Mean best-corrected visual acuity improved from 60 Early Treatment for Diabetic Retinopathy Study letters to 66.7 letters at 1 year, and to 70 letters at 2 years (p < 0.001). Mean central retinal thickness decreased from 459 ± 148 µm to 327 ± 163 µm and 261 ± 89 µm, respectively, at the first and the second year (p < 0.001).With respect to age-related macular degeneration patients, mean number of injections was 5.3 ± 2.2 at 1 year and 3.3 ± 1.5 at 2 years. Mean best-corrected visual acuity improved from 63 Early Treatment for Diabetic Retinopathy Study letters to 68 letters at 1 year and to 70 letters at 2 years (p < 0.001). Mean central retinal thickness was 411 ± 146 µm, decreasing to 271 ± 93 µm at 1 year and 260 ± 68 µm at 2 years (p < 0.001). Conclusions: Our study described the 2-year real-life outcome of anti–vascular endothelial growth factor treatment of diabetic macular edema and age-related macular degeneration.


2019 ◽  
Vol 30 (4) ◽  
pp. 764-769 ◽  
Author(s):  
Verónica Castro-Navarro ◽  
Enrique Cervera-Taulet ◽  
Catalina Navarro-Palop ◽  
Laura Hernández-Bel ◽  
Clara Monferrer-Adsuara ◽  
...  

Introduction: To analyze functional and anatomical outcomes in subtypes of diabetic macular edema treated with a single dexamethasone implant and to assess the usefulness of a pro-re-nata treatment among subtypes. Methods: Retrospective study in morphologic patterns of diabetic macular edema (diffuse retinal thickening n = 15; cystoid macular edema n = 38, and serous retinal detachment n = 17) recalcitrant to anti-vascular endothelial growth factor, treated with dexamethasone implant. Examinations included timing to recidive of diabetic macular edema, best-corrected visual acuity, and central subfield macular thickness at 2, 4, and 6 months. Results: In previously treated patients with a mean of 6.64 ± 3.69 anti-vascular endothelial growth factor injections, the best-corrected visual acuity improved from 61.64 ± 13.71 to 65.71 ± 14.65 as per the Early Treatment Diabetic Retinopathy Study protocol (p = 0.009) and central subfield macular thickness change from 447.46 ± 110.82 to 354.39 ± 80.46 µm (p < 0.005). The best-corrected visual acuity improvement was better in the diffuse retinal thickening group (68.67 ± 13.81 vs 65.26 ± 14.04 in cystoid macular edema and vs 64.12 ± 17.06 in serous retinal detachment), whereas higher central subfield macular thickness thinning was observed in serous retinal detachment group (368.47 ± 29.96 to 310.27 ± 67.47 in diffuse retinal thickening, vs 445.92 ± 105.06 to 364.39 ± 80.28 and 520.59 ± 122.96 to 370.94 ± 81.73 in cystoid macular edema and serous retinal detachment, respectively). Cystoid macular edema group was the group with more recurrences after 6 months (86.8% vs 66.7% in diffuse retinal thickening and 70.6% in serous retinal detachment). Conclusion: Dexamethasone implant is effective for all persistent diabetic macular edema subtypes with sustained functional and morphologic gains in the first 6 months.


2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Li Song ◽  
Fangtian Dong ◽  
Changxian Yi

Abstract Background Uveal effusion syndrome is a rare disease characterized by exudative detachments of the choroid, ciliary body, and retina. Various surgical procedures and nonsurgical strategies have been described to treat uveal effusion syndrome with limited success. The treatment for uveal effusion syndrome remains a serious challenge for clinicians. To the best of our knowledge, no previous report has described a severe uveal effusion syndrome patient with nanophthalmos treated by using an anti-vascular endothelial growth factor agent alone. We report here one such case with unexpected positive results. Case presentation A 30-year-old Chinese male patient presented with painless vision loss in both eyes that had persisted for 2 months. Examination of the right eye revealed a best corrected visual acuity of 0.03; the best corrected visual acuity of the left eye was finger count/20 cm. The intraocular pressure was normal on both eyes. A-scan revealed an right eye axial length of 15.88 mm and a left eye axial length of 16.21 mm. In the right eye, half of the peripheral choroid and nearly three-fourths of the retina were detached. The left fundus was not visible because of the total retinal detachment located just behind the lens, which could be clearly observed directly with a slit lamp. Considering all the possibilities and available treatments as well as the patient’s intentions after discussion, we first administered an intravitreal injection of ranibizumab 0.5 ml into both eyes. The patient’s visual perception improved 3 days after the injection. One month later, most of the effusion under the choroid and retina was absorbed. Visual acuity improved from finger count to 0.05 in both eyes, and vision quality was remarkably improved. Encouraged by this good result, the patient opted to undergo a second injection 1 month later. Choroidal and retinal detachment completely vanished 30 days after the second injection. Conclusions Using an anti-vascular endothelial growth factor agent alone may be a potentially effective and safe method for managing some types of uveal effusion syndrome, such as in nanophthalmos. The injection may be administered before considering more aggressive procedures in some uveal effusion syndrome patients.


2020 ◽  
pp. 112067212092996 ◽  
Author(s):  
Jorge Ruiz-Medrano ◽  
Ramón Rodríguez-Leor ◽  
Elena Almazán ◽  
Francisco Lugo ◽  
Esther Casado-Lopez ◽  
...  

Purpose To assess the functional and anatomical outcomes of intravitreal dexamethasone implant Ozurdex® in eyes with diabetic macular edema that did not adequately respond to vascular endothelial growth factor inhibitors. Methods Multicenter, retrospective, and real-life case series study conducted on consecutive diabetic macular edema patients who underwent treatment with one or more dexamethasone implant injections and were followed up for a minimum of 12 months. Subjects were divided into three groups: I—naïve patients, II—previously treated eyes that received three intravitreal antivascular endothelial growth factor inhibitors injections before the study (early switch), and III—previously treated eyes that received >3 intravitreal antivascular endothelial growth factor inhibitors injections before the study (late switch). Primary endpoints were best-corrected visual acuity and central retinal thickness at month 12. Results A total of 129 eyes (21 naïve and 108 previously treated, Group II: 32 and Group III: 76) were included. At month 12, best-corrected visual acuity significantly improved from 0.27 ± 0.23 and 0.31 ± 0.22 at baseline to 0.36 ± 0.25 and 0.37 ± 0.23 at month 12 in naïve and previously treated eyes, respectively, and p = 0.0063 and 0.0060, respectively. Central retinal thickness, in naïve and previously treated eyes, was significantly reduced from 483.0 ± 143.4 and 431.3 ± 115.5 µm, at baseline, to 278.8 ± 72.1 and 269.3 ± 66.2 µm, at month 12, respectively, and p < 0.0001 each, respectively. Best-corrected visual acuity improvement was significantly greater in both absolute and percentage values, p = 0.0393 and 0.0118, respectively, in Group II than in Group III. Conclusion In eyes with insufficient response to antivascular endothelial growth factor inhibitors, switching to dexamethasone at the time to 3-monthly antivascular endothelial growth factor inhibitors injections provided better functional outcomes than those that received >3 antivascular endothelial growth factor inhibitors injections.


2013 ◽  
Vol 29 (4) ◽  
pp. 392-401 ◽  
Author(s):  
Daniel A. Ollendorf ◽  
Jennifer A. Colby ◽  
Steven D. Pearson

Objectives: The aim of this study was to evaluate the comparative effectiveness of anti-vascular endothelial growth factor therapy in the treatment of diabetic macular edema (DME).Methods: Searches focused on reports concerning treatment of DME with aflibercept, bevacizumab, pegaptanib, or ranibizumab published between January 2000 and June 30, 2012, with comparisons to laser photocoagulation, sham injection, or other control (e.g., triamcinolone). Effectiveness was based on best-corrected visual acuity (BCVA), in terms of letters gained. Direct meta-analyses were conducted on BCVA for each anti-vascular endothelial growth factor (VEGF) agent; indirect comparisons also were performed for each anti-VEGF pair.Results: A total of fifteen randomized controlled trials (eleven fair- or good-quality) and eight observational studies were included. No direct comparative studies were identified. Improvement in visual acuity versus control was seen with all agents (range: 4–9 letters); outcomes were consistent across multiple timepoints. Meta-analyses showed no statistically significant and/or consistent differences between agents in BCVA changes or the percentage of patients gaining more than ten letters. No discernible differences in the potential harms of anti-VEGFs, including ocular events, MI, stroke, and other cardiovascular events, as well as death, were noted between aflibercept, pegaptanib, and ranibizumab. Data on harms for bevacizumab were underreported.Conclusions: All anti-VEGF agents are effective in improving visual acuity in comparison to laser photocoagulation. Evidence is insufficient to distinguish the performance of any single anti-VEGF agent over others. The safety of bevacizumab remains the greatest element of uncertainty.


2016 ◽  
Vol 236 (2) ◽  
pp. 67-73 ◽  
Author(s):  
Yoshito Koyanagi ◽  
Shigeo Yoshida ◽  
Yoshiyuki Kobayashi ◽  
Yuki Kubo ◽  
Muneo Yamaguchi ◽  
...  

Purpose: To compare the effectiveness of intravitreal ranibizumab (IVR) for diabetic macular edema (DME) between eyes with and without previous vitrectomy. Procedures: We prospectively assessed the best-corrected visual acuity (BCVA) and central macular thickness (CMT) after IVR for 6 months. Results: There were no significant differences in the baseline BCVA and CMT between both groups. In the nonvitrectomized group (n = 15), the mean changes of BCVA and CMT from baseline to month 6 were significant (p < 0.01). In the vitrectomized group (n = 10), the improvement appeared to be slower, and the mean BCVA improvement was not significant (p = 0.5), although the mean CMT decrease was significant (p < 0.05). There were no significant differences in the mean changes of BCVA and CMT between both groups at 6 months. Conclusions: The difference in the effectiveness of IVR between both groups was not significant. IVR can be a treatment option even for vitrectomized DME eyes.


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