Real-World Use of Off-Label MVASI in the Treatment of Patients With Neovascular AMD and DME.

Purpose: The purpose of this study was to evaluate the efficacy and safety of bevacizumab-awwb in the off-label treatment of neovascular age-related macular degeneration (n-AMD) and diabetic macular edema (DME). Methods: All patients with n-AMD and DME treated in the maintenance phase according to the "treat and extend" strategy, who underwent forced drug substitution from bevacizumab to bevacizumab-awwb from October 2022 to April 2023 at the Tor Vergata Polyclinic in Rome, were evaluated in a retrospective study. The primary outcome was changes in central retinal thickness (CRT) over time following drug substitution. The secondary outcomes were variations in drug durability, best corrected visual acuity (BCVA) and retinal fluid, and the incidence of drug-related local and systemic serious adverse events. Results: Of 80 eyes of 76 patients with n-AMD and 55 eyes of 44 patients with DME included, before and after drug substitution, the average CRT did not statistically differ; the proportion of patients within time intervals of q8, q12, and q16 was not different; and the mean BCVA remained constant. Of a cumulative 3496 bevacizumab-awwb treatments (2154 for patients with n-AMD and 1342 for patients with DME), no local severe complications were detected. Out of a total of 544 patients (342 affected by n-AMD and 202 affected by DME), no serious adverse events were reported. Conclusions: In our cohort of patients with n-AMD and DME in the maintenance phase, bevacizumab-awwb seems to represent a viable and cost-effective intravitreal therapy with comparable efficacy and safety to the originator. Translational Relevance: This study provides a preliminary assessment of the efficacy and safety of intravitreal bevacizumab-awwb, which is widely used off-label in retinal vascular diseases.

Association Between Alzheimer's Disease and Glaucoma: A Study Based on Heidelberg Retinal Tomography and Frequency Doubling Technology Perimetry.

AIM: To assess the frequency of glaucoma-like alterations in Alzheimer's disease (AD) patients using Heidelberg Retinal Tomograph III (HRT-3) and Frequency Doubling Technology (FDT) perimetry. METHODS: The study included 51 eyes of 51 AD subjects and 67 eyes of 67 age- and sex-matched controls. Subjects underwent an ophthalmological examination including measurements of intraocular pressure (IOP), Matrix FDT visual field testing, optic nerve head morphology and retinal nerve fiber layer thickness (RNFLt) assessment by slit-lamp biomicroscopy and HRT-3. RESULTS: The frequency of alterations was significantly higher in the AD group (27.5 vs. 7.5%; p = 0.003; OR = 4.69). AD patients showed lower IOP (p = 0.000) despite not significantly different values of central corneal thickness (CCT) between the groups (p = 0.336). Of all the stereometric parameters measured by HRT-3, RNFLt was significantly lower in AD patients (p = 0.013). This group also had significantly worse results in terms of Moorfields Regression Analysis (p = 0.027). Matrix showed significantly worse Mean Deviation (MD) (p = 0.000) and Pattern Standard Deviation (PSD) (p = 0.000) values and more altered Glaucoma Hemifield Test (p = 0.006) in AD patients. Pearson's R correlation test showed that Mini Mental State Examination is directly correlated with MD (R = 0.349; p = 0.034) and inversely correlated with PSD (R = -0.357; p = 0.030). CONCLUSION: Patients with AD have a higher frequency of glaucoma-like alterations, as detected by the use of HRT-3. These alterations were not associated with elevated IOP or abnormal CCT values.

Correlation between pathological data and the RNA expression of p53 or p53-targeted genes in primary invasive ductal breast carcinomas: a preliminary study.

The protein expression of the growth suppressive p53 transcription factor and its inhibitor human double minute 2 (Hdm2) is altered in ductal breast carcinomas (DBC). However, the assessment of p53 and/or Hdm2 protein levels in DBC tissues was found to have a questionable prognostic significance. We evaluated the RNA expression of p53, hdm2, and the p53-targeted p21waf-1 and thrombospondin (tsp)-1 by primary DBC tissues, then correlated the RNA levels with patient clinicopathological data. The mean RNA expression level of p53 and that of hdm2 were elevated in large-sized, poorly differentiated, node-positive DBC, while a high p21waf-1 or tsp-1 mean expression level comprised small-sized, low-grade, node-negative tumors. Further analyses found that the correlation between the RNA expression of p53 and that of its targeted genes was reduced as tumor aggressiveness increased. However, for all the examined genes, association of the intensity of RNA expression with the pathological data was not statistically significant (p>0.05). Altogether, our preliminary RNA data confirm the results from previous protein studies, indicating that despite p53 expression and activity show a trend to vary in association with DBC clinical features, neither p53 nor its transcriptional targets can accurately monitor the behaviour of invasive DBC.