Systemic and vitreous biomarkers - new insights in diabetic retinopathy.

PURPOSE: Diabetic retinopathy (DR) is a microvascular inflammatory and neurodegenerative disease. The purpose of this study was to analyze the relationship between DR severity and the levels of potential biomarkers in the serum and/or vitreous. METHODS: A prospective, consecutive, controlled, observational study was performed between June 2018 and January 2020. Blood and vitreous samples were collected on the day of vitrectomy in patients without diabetes and in patients with diabetes with epiretinal membrane, macular edema, and indication for vitrectomy. RESULTS: Transthyretin (TTR) was the only blood biomarker with levels statistically higher in patients with diabetes (p = 0.037). However, no correlation with DR severity was observed. Erythropoietin (EPO) was the only blood biomarker whose levels were associated with DR severity (p = 0.036). In vitreous samples, levels of EPO (p = 0.011), interleukin (IL)-6 (p < 0.001), IL-8 (p < 0.001), IL-17 (p = 0.022), monokine induced by interferon-γ (MIG) (p < 0.001), and interferon gamma-induced protein 10 (IP-10) (p = 0.005) were significantly higher in patients with diabetes. Additionally, in vitreous, IL-6, IL-8, MIG, and IPL-10 levels were also higher in more severe DR cases (p < 0.05). CONCLUSIONS: Among the studied biomarkers, vitreous IL-6, IL-8, MIG, and IP-10 were the ones whose levels had the strongest coherent relationship with DR severity prediction and, thus, have the best potential post-vitrectomy prognostic value.

Preoperative color Doppler ultrasound parameters for surgical decision-making in upper arm arteriovenous fistula maturation.

OBJECTIVE: Current scientific evidence is insufficient to determine the best vascular access for each patient. It is an unmet clinical need because vascular access dysfunction accounts for 20% to 30% of hospital admissions. Our aim was to evaluate preoperative color flow Doppler ultrasound (CDUS)-derived parameters (vein diameter and brachial artery flow and diameter) and their effect interaction with comorbidities as predictors of brachiocephalic (BC) and brachiobasilic (BB) arteriovenous fistula (AVF) maturation. METHODS: A prospective analysis was performed of patients who underwent BC and BB AVF as primary definitive vascular access between January 2016 and May 2017. Variables included patients' demographics, comorbidities, medication, preoperative blood pressure, and CDUS-derived parameters. Outcomes were patency 48 hours after surgery and fistula maturation at 6 and 12 weeks. Nonparametric descriptive and univariate statistics were used. Logistic regression models and receiver operating characteristic curve analyses were performed. RESULTS: There were 132 patients (91 with BC AVF and 41 with BB AVF) included. The 48-hour patency was 91.7%. AVF maturation at 6 weeks was observed in 71.3%, and AVF maturation at 12 weeks was observed in 66.3%. There were no associations in univariate and multivariate logistic regression analysis between AVF maturation and comorbidities. Systolic blood pressure was an independent predictor of 48-hour patency with an optimized cutoff of 154 mm Hg (area under the curve, 0.73; P = .013; Youden index, 0.40). Vein diameter with tourniquet was an independent predictor of AVF maturation at 6 and 12 weeks with an optimized cutoff of 3.9 mm (area under the curve, 0.74; P < .001; Youden index, 0.38). CONCLUSIONS: AVF maturation was independent of comorbidities. Systolic blood pressure ≥154 mm Hg and vein diameter with tourniquet ≥3.9 mm were the associated conditions that better predicted BC and BB AVF maturation. There were no effect interactions between CDUS-derived parameters and associated comorbidities.

Effect of biologic disease-modifying anti-rheumatic drugs targeting remission in axial spondyloarthritis: systematic review and meta-analysis.

OBJECTIVES: To assess the efficacy of biologic DMARDs (bDMARDs) in achieving Assessment of Spondyloarthritis International Society partial remission (ASAS-PR) and/or Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS-ID), as remission-like surrogates, in axial SpA (axSpA). METHODS: Data from randomized controlled trials (RCTs), including long-term extensions, were included. A systematic literature review was performed using the MEDLINE database (first search May 2018, updated February 2020) and PICO criteria according to Patients-adults with radiographic or non-radiographic axSpA; Intervention-any bDMARD; Comparator-placebo and/or any different drug; Outcomes-ASAS-PR and/or ASDAS-ID as primary or secondary endpoints. Meta-analysis was performed after assessment of the homogeneity of study designs, populations and outcomes. RESULTS: After screening 155 references, a total of 22 RCTs and 28 long-term extensions were retrieved. ASAS-PR was the dominant remission-like definition used. Concerning TNF inhibitors, 14/17 RCTs provided evidence of efficacy in reaching remission at different time points: 12, 16, 24 and 28 weeks (ASAS-PR in 16-62% of patients and ASDAS-ID in 24-40% of patients). With a limited number of studies available, IL-17A inhibitors exhibited remission rates of 15-21% for ASAS-PR and 11-16% for ASDAS-ID at week 16. A meta-analysis regarding ASAS-PR was performed considering RCTs with a similar duration (12, 16 or 24 weeks). The relative risk for achieving remission was 3.864 (95% CI 2.937, 5.085). CONCLUSION: bDMARDs have a clear impact in axSpA remission evaluated by ASAS-PR. Nevertheless, these data show an unmet need for improved reporting of remission-like outcomes.

The role of prediagnostic data in injury epidemiology in preprofessional dancers.

INTRODUCTION: preprofessional dance training starts at very early ages, on a highly demanding environment placing students at significant risk for injury. Injury management and prevention are a matter of concern. Given the constant interchangeability of risk factors, identifying injury patterns may prove to be equally as important. Data looking back from the time of injury through context-specific approaches are missing. OBJECTIVES: To identify activity-related injury patterns based on prediagnostic data. METHODS: Prospective, non-randomized, observational study, over a 3 years period on a full-time preprofessional dance school featuring both gender students aged 9-21 years old. Non-parametric statistics were used. RESULTS: A total of 625 dance injury records from 209 students, n = 68 males and n = 141 females, were analyzed. Season injury risk probability was identified, proving different for each skill level (SkL). Multiple individual injuries revealed a trend toward prevalence rates in advanced level, while index injuries incidence becomes more noticeable in entry level students. Overall incidence rates had no significant differences within SkL. Anatomical location was in line with previous research, although differences were found between gender and SkL. Most injuries occurred in classes, with jumps standing out as the main motor action associated with injury symptoms of gradual onset mechanism. CONCLUSION: Dance injuries happen because of dance practice. Knowing the context of injury history from the injured dancer perspective is determinant for management and prevention. prediagnostic data are an umbrella term encompassing several aspects of injury background and represents fertile ground for research. Context-specific methodological approaches are recommended.

Vitrectomy Outcomes in Eyes with Tractional Diabetic Macular Edema.

PURPOSE: To evaluate pars plana vitrectomy (PPV) outcomes in cases with tractional diabetic macular edema (tDME). METHODS: We conducted a single-center retrospective study with a follow-up of 12 months. Forty-six eyes with tDME of 38 patients submitted to PPV between 2013 and 2015 were assessed. A standard PPV was performed and surgical outcomes were registered at the 3-, 6-, and 12-month follow-up. RESULTS: The baseline median best corrected visual acuity (BCVA) in ETDRS (Early Treatment Diabetic Retinopathy Study) letters and the median central foveal thickness (CFT) were 43.0 letters and 491.0 µm, respectively. At the 12-month follow-up, a median decrease in CFT of 232.7 µm was observed. A CFT < 300 µm was achieved in 65.2% of the cases (52.2% needing no further treatment); a BCVA improvement by ≥10 letters was achieved in 60.0%, but there was a decrease of ≥10 letters in 13.0% of the cases. DME recurrence was observed in 10.9% of the cases, with a median time of development after vitrectomy of 6 months. As a major postoperative complication, a macular hole was observed in 1 patient (2.1%). CONCLUSIONS: In our series, PPV for tDME induced an improvement in retinal thickening and visual outcome in more than 50% of the cases, with low recurrence rates and a low number of postoperative complications.

Ranibizumab for the Treatment of Diabetic Macular Oedema in the Real-World Clinical Setting in Portugal: A Multicentre Study.

PURPOSE: The purpose of this study was to evaluate the 2-year outcome of ranibizumab for diabetic macular oedema (DME) in the real-life clinical practice of five ophthalmology departments of the National Health Service (NHS) in Portugal. METHODS: This is a retrospective multicentre study. The clinical records on consecutive patients with DME from clinical practice treated with 0.5 mg intravitreal ranibizumab and followed up for 24 months were reviewed. Efficacy outcomes comprised the change in best corrected visual acuity (BCVA) and central macular thickness (CMT) evaluated by SD-OCT. Multivariate regression analysis was performed to explore predictors of BCVA. RESULTS: A total of 122 eyes of 93 patients were included. The median BCVA change by 24 months was +5.0 letters (IQR 12.0) (p < 0.001) and the CMT change was -89.0 µm (IQR 165.0) (p < 0.001). By 24 months, 21.4% of the eyes had gained ≥15 letters and 8.6% had lost ≥15 letters. The median number of injections given during follow-up was 5.0 (IQR 4.0). A greater baseline CMT and a more disrupted status of the external limiting membrane were predictive of worse BCVA at 24 months (p ≤ 0.015). CONCLUSION: DME treatment with ranibizumab in the Portuguese NHS is associated with anatomic and functional improvement by 2 years; however, our results are below those reported in major clinical trials, and undertreatment is probably the cause.

Programming of Essential Hypertension: What Pediatric Cardiologists Need to Know.

Hypertension is recognized as one of the major contributing factors to cardiovascular disease, but its etiology remains incompletely understood. Known genetic and environmental influences can only explain a small part of the variability in cardiovascular disease risk. The missing heritability is currently one of the most important challenges in blood pressure and hypertension genetics. Recently, some promising approaches have emerged that move beyond the DNA sequence and focus on identification of blood pressure genes regulated by epigenetic mechanisms such as DNA methylation, histone modification and microRNAs. This review summarizes information on gene-environmental interactions that lead toward the developmental programming of hypertension with specific reference to epigenetics and provides pediatricians and pediatric cardiologists with a more complete understanding of its pathogenesis.

Kaplan-Meier Survival Analysis: Practical Insights for Clinicians.

This article aims to provide a guide that will help healthcare professionals and clinical researchers from all fields that deal with Kaplan-Meier curves. Survival analysis methods are among the most frequently used in the medical sciences and in clinical research. Overall survival, progression free survival, time to recurrence, or any other clinically relevant parameter represented by a Kaplan-Meier curve will be discussed. We will present a practical and straightforward interpretation of these curves, setting aside intricate mathematical considerations. Our focus will be on essential concepts that interface with biological sciences and medicine in order to guarantee proficiency in one of the most popular yet frequently misunderstood methods in clinical research. Being familiar with these concepts is not only essential for designing new clinical studies but also for critically assessing and interpreting published data.

The role of low-molecular-weight protein tyrosine phosphatase (LMW-PTP ACP1) in oncogenesis.

Protein tyrosine phosphorylation is a crucial cellular event that is involved in the most important processes of cellular metabolism. Low-molecular-weight protein tyrosine phosphatase (LMW-PTP) is a tyrosine phosphatase that presents two active distinct isoforms and is regulated through cysteine oxidation and tyrosine phosphorylation. This enzyme has been linked to tumorigenesis, but its role is considered controversial: it may be considered oncogenic or anti-oncogenic depending on its interaction with different substrates. Furthermore, recent studies have demonstrated that LMW-PTP is involved in epithelial cell migration, a characteristic of tumor cells. This fact strengthens the importance of this enzyme in the oncogenic process and opens new avenues for future research. The study of LMW-PTP and its pathways may enhance therapeutic strategies that target tyrosine phosphorylation and its substrates. In this review, we try to clarify the importance of this protein in carcinogenesis through the analysis of LMW-PTP interaction with different substrates.

Oct biomarkers for early prognosis in diabetic macular edema treatment with ranibizumab.

BACKGROUND: Diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In this work, we aimed to assess the role of Optical Coherence Tomography (OCT) biomarkers in patients treated with ranibizumab. METHODS: A prospective study enrolling 46 eyes with DME under ranibizumab intravitreal therapy with 12 months of follow-up. The primary endpoint was to assess the association between OCT biomarkers at baseline and the type of treatment response. RESULTS: Good responders, compared with partial/non responders, had lower number of inner nuclear layer cysts (INLc) at baseline, (26.5% vs 73.5%, p = 0.035) and presented, at 12 months of follow-up, lower percentage of disorganization of retinal inner layers (12.0% vs 88.0%, p = 0.001), lower disruption of outer plexiform layer (8.7% vs 91.3%, p < 0.001) and lower outer nuclear layer cysts (17.4% vs 82.6%, p = 0.013). At the end of follow-up, it was observed a higher frequency of inner nuclear layer cysts in patients with higher glycated haemoglobin (p = 0.028). CONCLUSION: This study showed the value and importance of OCT parameters, such as absence of INLc, as a prognostic therapeutic response. A normalization of the macular anatomy with ranibizumab is more likely to happen in early complete responders. The association between INLc and higher glycated haemoglobin levels showed the importance of systemic metabolic control in systemic diabetic manifestations. Clinicaltrials.gov NCT04387604.

Incidence and Risk Factors for Retinopathy of Prematurity in a Portuguese Cohort.

PURPOSE: To evaluate the incidence and risk factors for retinopathy of prematurity (ROP) in two Portuguese neonatal units with a sub-analysis of infants with a gestational age (GA) of 28 weeks or older. METHODS: This was a retrospective case series of all infants who underwent ROP screening from 2012 to 2020. Demographic, clinical, and laboratory data were collected. Univariate logistic regression was used to examine the risk factors for ROP followed by multivariate regression. RESULTS: A total of 475 infants were included with a median GA of 30 weeks (range: 23 to 36 weeks) and a median birth weight of 1,229 grams (range: 408 to 2,620 grams). ROP was diagnosed in 113 infants (23.8%) and 29 (6.1%) were treated. In the multivariate analysis, GA and hyperglycemia were significantly associated with severe ROP (P < .001). In the subgroup analysis of infants with a GA of 28 weeks or older, bronchopulmonary dysplasia, late-onset sepsis, and hyperglycemia were linked to severe ROP. CONCLUSIONS: The incidence of ROP in the cohort falls within the range of other high-income countries. Hyperglycemia overpowered all of the other risk factors. Although rare, more mature infants are also at risk for severe ROP. Infants with older GA share the same group of risk factors, but bronchopulmonary dysplasia seems to play a greater role. [J Pediatr Ophthalmol Strabismus. 2022;59(4):254-260.].

Retrospective comparison between growth and retinopathy of prematurity model versus WINROP model.

OBJECTIVE: To compare the weight and insulin-like growth factor-1 in neonatal retinopathy (WINROP) to the growth and retinopathy of prematurity (G-ROP) model in a Portuguese cohort. DESIGN: Retrospective case series. METHODS: Clinical records of consecutive infants who underwent retinopathy of prematurity (ROP) screening from April 2012 to May 2019 were retrospectively reviewed. Both WINROP and G-ROP models were accessed for sensitivity and specificity for type 1 ROP. A separate analysis of both algorithms was performed in infants with gestational age (GA) <30 weeks. RESULTS: Of the 375 infants included in the study, 313 were eligible for G-ROP analysis and 311 for WINROP. In the G-ROP group, 22 infants developed type 1 ROP (sensitivity 90.91%, 95% confidence interval [CI] 70.84%-98.98%). In the WINROP group, 23 infants needed treatment (sensitivity of 86.96%, 95% CI 66.41%-97.22%). Both models reached 100% sensitivity for type 1 ROP if restricted to GA <30 weeks. CONCLUSIONS: Both models were easy to use and had similar sensitivities. If restricted to GA <30 weeks, both models detected all type 1 ROP.

DIGIROP efficacy for detecting treatment-requiring retinopathy of prematurity in a Portuguese cohort.

BACKGROUND/OBJECTIVES: To determine the efficacy of the DIGIROP model in detecting treatment-requiring retinopathy of prematurity (TR-ROP) in a Portuguese cohort. SUBJECTS/METHODS: Multicentre, retrospective cohort study of all consecutive preterm infants who underwent ROP screening from April 2012 to May 2019 in two neonatal units. Gestational age (GA), birth weight (BW) and sex were inserted in the DIGIROP platform. The optimal cut-off point to achieve 100% sensitivity was calculated. Area under the receiver operating characteristic curve (AUC) was calculated. RESULTS: Of the 431 infants who underwent ROP screening, 257 were eligible for DIGIROP analysis and 174 infants were excluded for having a GA outside the range 24-30 weeks imposed by the DIGIROP algorithm. Median GA was 29 weeks (range 24-30) and BW was 1060 g (range 408-2080). Twenty-tree infants (8.9%) developed TR-ROP. The highest risk obtained for TR-ROP was 0.5404 (95% CI 0.4343-0.6616) with a median achieved risk of 0.0938 (range 0.0016-0.5404). The optimal cut-off point to achieve 100% sensitivity on TR-ROP was 0.0016. The number of infants receiving ROP examinations would have been reduced from 257 to 187 infants (-27.2%) if the model was applied. CONCLUSIONS: In our cohort, of 257 infants, the optimal cut-off point to achieve 100% sensitivity for TR-ROP was 0.0016 with moderate accuracy in the AUC (0.70). The number of infants requiring screening would have decreased 27.2% if the model was applied. It is essential that algorithms continue to be tested in different populations, especially in cohorts that include both younger and older GA infants.

Predictors of Photic Phenomena with a Trifocal IOL.

AIM: To assess predictive factors associated with glares and halos in patients undergoing cataract surgery with PanOptix trifocal IOL implantation. METHODS: Single-center retrospective study. One hundred and forty eyes from 70 patients with cataract were bilaterally implanted with a trifocal PanOptix aspherical diffractive lens between 2017 and 2019 and followed-up for six months. All patients were evaluated for refraction, corneal topography, and aberrometry pre- and post-operatively. Patients were assessed at 1 day, 6 days, 1 and 6 months after surgery. One and six months post-operatively patients were asked to complete a satisfaction questionnaire that included photic phenomena assessment. Main outcome measures were photic phenomena at 1 and 6 months of follow-up. Predictors of photic phenomena at 1 and 6 months were also analyzed. RESULTS: A higher corneal coma was associated with more mild halos at 6 months with no association regarding other degrees of severity. The lower the age the higher the glare or halos, the higher the lens thickness and the lower the anterior chamber depth or chord µ the less halos at 1 month. A significant proportion of patients had more none/mild compared to moderate/severe glare and halos both at 1 and 6 months post-operatively. Baseline BCVA was the only predictor of halos at 1 month and glare and halos at 6 months post-surgery. CONCLUSION: On multivariate regression analyses, the only predictor of photic phenomena was baseline visual acuity, suggesting that patients that have a better visual acuity before surgery are more demanding regarding visual outcomes after surgery.

Biologic disease-modifying anti-rheumatic drugs and patient-reported outcomes in axial SpA: a systematic review and a call for action.

This paper is to assess the efficacy of different biologic DMARDs (bDMARDs) on several patient-reported outcomes (PROs) in randomized controlled trials (RCT) in axial spondyloarthritis (axSpA). A systematic literature review (SLR) was performed. MEDLINE (May 1, 2018) was used with the filters "published in the last 10 years" and "humans." The PICO criteria used were Patients: adults with radiographic axSpA (r-axSpA) or non-radiographic axSpA (nr-axSpA); Intervention: any bDMARD; Compararator: placebo (PBO)/any different drug; Outcome: the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), the Ankylosing Spondylitis Quality of Life (ASQoL), the EuroQol-5D (EQ-5D), the Short Form 36 Health Survey physical component summary (SF36-PCS), the Short Form 36 Health Survey mental component summary (SF36-MCS), and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). After screening 84 initial references and manually selecting other 9, 24 publications, assessing TNF inhibitors (TNFi) or IL17A inhibitors (IL17Ai) were selected. Four RCTs quantified the minimal clinical important difference (MCID) between treatment arms. Most of the RCTs compared the mean difference of PROs between different timepoints. Overall, the treatment arm was superior to the comparator. PROs were often underreported or highly heterogeneously presented. MCID was seldom mentioned. There is a need to raise the standard of care on SpA by aiming at remission and PRO associated improvements. In order to achieve this goal, the target must be clearly defined, reported, and tested.

Choroidal Blood Flow After Intravitreal Ranibizumab in Vitrectomized and Non-Vitrectomized Eyes with Diabetic Macular Edema.

AIM: Diabetic retinopathy staging system and progression predictors are soon to be considered insufficient for ophthalmologic practice. Given the growing evidence of the role of choroidal dysfunction, our purpose was to assess choroidal vascular changes with intravitreal ranibizumab (RBZ) treatment in diabetic macular edema (DME). METHODS: This was a prospective longitudinal cohort study. The study included DME eyes, grouped in vitrectomized (group 1) and non-vitrectomized (group 2) eyes, submitted to RBZ in a pro re nata regimen, with 24 weeks of follow-up. Main outcome measures such as central subfield foveal thickness (CFT), choroidal thickness (CT), and choroidal vascular index (CVI) were obtained from structural OCT, and choriocapillaris flow density (CCD) was obtained from OCT angiography and analyzed before and after treatment. RESULTS: Thirty-one patients were included, 10 eyes in group 1 and 24 eyes in group 2. The mean number of injections was 5.18 (range 2-6). Globally, there was an improvement in BCVA (+4.3 ETDRS letters, p=0.004) and CFT (-84.6 µm, p<0.001) with no changes in CT, CVI, or CCD (p>0.05). When considering only group 2, there was a significant decrease in CT (p=0.033) and a significant increase in CCD (p=0.010) 6 months after treatment, with no differences in CVI (p=0.111). Baseline CVI was correlated with visual acuity at week 24 both globally (r=0.406, p=0.029) and in group 2 (r=0.604, p=0.004). CONCLUSION: In non-vitrectomized eyes, choriocapillaris blood flow improves with RBZ. Baseline CVI may correlate with visual function after RBZ. ClinicalTrials.gov NCT04387604.

Correlation between hyperglycemia and glycated albumin with retinopathy of prematurity.

To determine the association between hyperglycemia, glycated albumin (GlyA) and retinopathy of prematurity (ROP). Prospective study of all infants under ROP screening from March 2017 to July 2019. All demographic, clinical and laboratory data were collected. Glucose was measured at birth and every 8 h for the first week and serum GlyA was evaluated at birth, 1st, 2nd and 4th weeks after birth. Reference range for GlyA was obtained. Univariate logistic regression was used to examine risk factors for ROP followed by multivariate regression. A total of 152 infants were included in the study. Median gestational age was 30 weeks and median birth weight 1240 g. Thirty-three infants (21.7%) had ROP. Hyperglycemia was present in 24 (72.7%) infants diagnosed with any ROP versus 6 (0.05%) in those without ROP. Median GlyA at birth, 1st, 2nd and 4th and respective reference ranges were 8.50% (6.00-12.65), 8.20% (5.32-11.67), 8.00% (5.32-10.00) and 7.90% (5.30-9.00) respectively. After multivariate logistic regression, hyperglycemia but not GlyA, remained a significant risk factor for ROP overpowering the other recognized risk factors (Exp (B) 28.062, 95% CI for Exp(B) 7.881-99.924 p < 0.001). In our cohort, hyperglycemia but not GlyA, remained a significant risk factor for ROP overpowering the other recognized risk factors.

Vitrectomized versus non-vitrectomized eyes in diabetic macular edema response to ranibizumab-retinal layers thickness as prognostic biomarkers.

To evaluate the role of the vitreous in the management of diabetic macular edema with ranibizumab intravitreal injections in a pro re nata regimen. Prospective study of 50 consecutive eyes with diabetic macular edema treated with ranibizumab and 12 months of follow-up. Primary endpoint: to assess differences between non-vitrectomized and vitrectomized eyes in the number injections needed to control the edema. Secondary endpoints: comparison of groups regarding best corrected visual acuity, central foveal thickness and thickness of seven retinal layers. 46 eyes from 38 patients, 10 vitrectomized and 36 non-vitrectomized, completed the follow-up. At month 12, the two groups achieved an equivalent anatomical outcome and needed a similar number of ranibizumab intravitreal injections. In vitrectomized eyes final visual acuity was worse when baseline retinal nerve fiber layers in the central foveal subfield were thicker, showing a strong correlation (r = - 0.942, p < 0.001). A similar, albeit moderate correlation was observed in non-vitrectomized eyes (r = - 0.504, p = 0.002). A decrease of retinal nerve fiber layers inner ring thickness was correlated with a better final visual acuity only in vitrectomized eyes (r = 0.734, p = 0.016). The effect of diabetic macular edema seems to be worse in vitrectomized eyes, with a thinner inner retina reservoir.Clinicaltrials.govNCT04387604.

Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema: Exploratory Retrospective Analysis.

AIM: To evaluate the efficacy of switching from bevacizumab to ranibizumab or aflibercept in eyes with diabetic macular edema (DME) unresponsive to bevacizumab. METHODS: Single-center retrospective comparative study of patients with DME unresponsive to intravitreal bevacizumab that was switched to ranibizumab or aflibercept. Best-corrected visual acuity (BCVA) and central foveal thickness (CFT) were analysed prior to and 4 months after the switch. Ocular coherence tomography (OCT) biomarkers were also analysed. RESULTS: Fifty-six eyes from 40 patients were included in the study, 33 eyes switched to ranibizumab and 23 to aflibercept. A significant median CFT decrease was observed in both groups (p<0.001), with no between-group differences. BCVA gain was only significant in the ranibizumab group (p<0.001). None of the pre-baseline or baseline parameters were associated with the response to ranibizumab or aflibercept. CONCLUSION: In persistent DME unresponsive to bevacizumab, both anatomical and functional improvements were observed with ranibizumab whereas aflibercept only showed an anatomical improvement. Clinicaltrials.gov NCT04018833.