Evaluating the Efficacy and Safety of Aflibercept Biosimilar (P041) Compared with Originator Product in Patients with Neovascular Age-Related Macular Degeneration.

OBJECTIVE: To assess the noninferiority of biosimilar aflibercept (P041, CinnaGen) to the originator aflibercept (AFL, Regeneron) in terms of efficacy, safety, and immunogenicity. DESIGN: This was a phase Ш, 52-week, multicenter, randomized, double-masked, and active control trial involving eyes in a 1:1 ratio. SUBJECTS: Patients with active subfoveal choroidal neovascularization secondary to age-related macular degeneration randomized into the 2 groups of P041 and AFL. METHODS: Patients received an injection of aflibercept every 4 weeks for 3 doses, followed by administration every 8 weeks up to week 48. MAIN OUTCOME MEASURES: The primary outcome was the noninferiority analysis of eyes maintaining vision at week 52. Secondary outcomes included the changes in visual acuity and retinal thickness, safety evaluation, and immunogenicity during the study. RESULTS: In total, 168 eyes of 168 patients were included. At week 52, the proportion of patients maintaining vision was 94.44% in the P041 group compared with 94.52% in the AFL group. The 95% confidence interval (CI) for the difference of maintaining vision from baseline did not exceed the predefined noninferiority margin of 10% (difference, -0.0008; 95% CI, -0.074 to 0.074; P = 0.98). Secondary outcomes indicated similar results in both arms (all P > 0.05). Safety measured outcomes and immunogenicity were similar between the 2 study groups. CONCLUSIONS: Biosimilar aflibercept was noninferior to AFL in eyes with neovascular age-related macular degeneration. Other efficacy and safety findings also indicated the similarity of 2 products. FINANCIAL DISCLOSURES: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Prevalence of age-related macular degeneration in Iran and its projections through 2050: a systematic review and meta-analysis.

BACKGROUND: Age-related Macular Degeneration (AMD) is one of the most common causes of vision loss. A substantial increase in the burden of AMD is expected in the aging populations, including the Iranians. We investigated the age and gender-specific prevalence of AMD and its determinants in Iran. METHODS: We systematically searched international (PubMed, Scopus, Embase, etc.) and local (IranDoc, Magiran, etc.) online databases. We included cross-sectional or cohort studies, either clinic- or population-based, published on the prevalence of AMD among Iranians, with no limitation on age. Joanna Briggs Institute (JBI) tools for critical appraisal were used. Prevalence estimates are pooled by applying random-effects modeling. Subgroup analysis and meta-regression were performed. RESULTS: Seventeen studies with 16,120 participants were included. Based on studies in general population, the pooled prevalence of AMD was 10.8% (95% CI: 6.5-16.2%) in males, and 9.8% (95% CI: 4.7-16.4%) in females. 8.5% of moderate vision impaired, 13.6% of severe vision impaired, and 15.7% of blind participants were affected by AMD. The prevalence of AMD was 2% in 40-49, and 32.3% in the ≥ 80 population. The prevalence of AMD was 11.9% among the visually impaired vs. 8.7% in the general population. The study's sampling method, location, and mean age were correlated with the heterogeneities of the prevalence. We observed an increasing trend in the number of AMD cases (average annual percent change = 3.66%; 95% CI: 3.65-3.67%) from 1990 to 2050. The expected number of AMD cases in Iran will be near 5.5 million by 2050. CONCLUSION: The prevalence of AMD in Iran was somewhere between the prevalence of Asians and Europeans. Given the aging trend of the Iranian community and an average annual percent change of 3.66%, it is indispensable to adopt preventive and screening policies to diminish the burden of the disease in the future decades.

Optical coherence tomography findings in patients with transfusion-dependent ß-thalassemia.

BACKGROUND: Structural ophthalmologic findings have been reported in patients with ß-thalassemia due to chronic anemia, iron overload, and iron chelation therapy toxicity in few previous studies. We aimed to investigate structural ocular findings and their relationship with hematological parameters in patients with transfusion-dependent ß-thalassemia (TDT). METHODS: In this cross-sectional study, from January 2018 to January 2019, 39 patients with TDT over the age of 18 participated. Multicolor fundus imaging, optical coherence tomography (OCT), and blue light fundus autofluorescence imaging were performed for all patients and 27 age- and sex-matched controls. RESULTS: The mean age of patients was 28.6 ± 6.2 years. The central macular thickness and macular thicknesses in all quadrants were significantly thinner in patients than controls (P<0.05). None of the retinal nerve fiber layer (RNFL) measurements were significantly different between TDT patients and controls. There was a significantly negative correlation between hemoglobin with central macula thickness (r=-0.439, P=0.005). All measurements of macular subfield thickness were insignificantly thinner in patients with diabetes mellitus (DM) compared to the non-DM subgroup. CONCLUSIONS: Macular thickness was significantly thinner in central macula and entire quadrants in TDT patients compared to healthy individuals; however, all RNFL measurement thicknesses were comparable between the two groups. Close monitoring of TDT patients by periodic ophthalmologic examinations with more focus on diabetic patients, patients with severe anemia and iron overload should be warranted.

Effect of calcium dobesilate on retrobulbar blood flow and choroidal thickness in patients with non-proliferative diabetic retinopathy.

INTRODUCTION: Diabetic retinopathy is one of the most common causes of blindness in work-aging adults and develops in one third of diabetic patients. Calcium dobesilate (CaD) treatment have protective effects on blood retinal barrier (BRB) and anti-oxidant as well as anti-inflammatory properties. OBJECTIVES: To assess effects of CaD administration on retrobulbar blood flow and choroidal thickness in patients with diabetic retinopathy. METHODS: In this quasi-experimental study, diabetic patients with diabetic retinopathy (DR) were recruited from Shahid Motahari and Poostchi ophthalmology clinic affiliated to Shiraz University of Medical Sciences. Patients were treated with CaD, 1 gr per day for seven days. Before and after CaD administration, retrobulbar blood flow and subfoveal choroidal thickness were assessed. Retrobulbar blood flow were evaluated by measuring peak systolic velocity (PSV), end diastolic velocity (EDV) and resistive index (RI) of ophthalmic artery (OA), central retinal artery (CRA) and short ciliary artery (SCA). RESULTS: In this study, 26 DR patients with a mean age of 56.15 ± 8.93 years and mean diabetes mellitus duration of 15.04 ± 7.64 years were enrolled. Subfoveal choroidal thickness was significantly increased from 316.08 ± 61.69 to 327.81 ± 58.03 after CaD treatment (P value < 0.001). PSV of CRA and EDV of all arteries were significantly increased after CaD administration. In addition, RI of all arteries was significantly reduced after CaD treatment (P < 0.001). CONCLUSION: CaD treatment may improve the ophthalmic blood flow and increase the subfoveal choroidal thickness in DR patients. These results may be suggestive of protective effects of CaD on endothelium function as well as microvascular circulation.

Ocular Manifestations of Patients with Coronavirus Disease 2019: A Comprehensive Review.

Apart from conjunctival involvement which is the most well-known ocular manifestation of coronavirus infectious disease 2019 (COVID-19), there are multiple reports of the involvement of other ocular structures by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We comprehensively reviewed PubMed, Scopus, Embase, and Google Scholar for available evidence regarding COVID-19 various ocular manifestations, with special focus on less known and unusual ocular findings. We then categorized the findings based on the parts of the eye which was involved. In anterior sections of the eye, the involvement of the eyelid (tarsadenitis), conjunctiva and cornea (follicular conjunctivitis, pseudomembranous conjunctivitis, and keratoconjunctivitis), episclera (nodular episcleritis), uvea (anterior uveitis) were reported. Also, third, fourth, and sixth nerve palsy, retinal vasculitis, retinal optical coherence tomography (OCT) changes (hyper-reflective lesions and increased retinal nerve fiber layer thickness [RNFLT]), optic neuritis, papillophlebitis, Miller Fisher syndrome, posterior reversible leukoencephalopathy (PRES), ophthalmic artery and central retinal artery occlusion, and polyneuritis cranialis were reported in different studies. Postmortem evaluation of COVID-19 patients detected no viral RNA in different anterior and posterior segments of the eyes. However, another study revealed a 21.4% positivity of the retinal biopsies of dead patients. The results of this study can help ophthalmologists to be vigilant when they see these findings in a suspected case of COVID-19. In addition, wearing face masks and protective goggles or eye shields are recommended, especially in high risk contacts.

Ocular findings in patients with transfusion-dependent ß-thalassemia in southern Iran.

BACKGROUND: Ocular involvement may occur via several mechanisms in patients with transfusion-dependent ß-thalassemia (TDT) mainly chronic anemia, iron overload and iron chelator toxicity. We aimed to evaluate the frequency of abnormal ocular findings and their relationship with hematologic parameters in TDT patients. METHODS: In this cross-sectional study from January 2018 to January 2019, a total of 79 patients with TDT over the age of 18 who were on iron-chelation therapy (ICT) were consecutively investigated. All patients were registered at the Thalassemia Comprehensive Center affiliated with Shiraz University of Medical Sciences, Shiraz, Southern Iran. Complete ophthalmic examination was performed by an expert ophthalmologist. Clinical and hematologic parameters were collected from the patients´ medical records. RESULTS: The mean age ± standard deviation (SD) of the patients was 28.4 ± 5.6 years (range: 18-43). Twenty-four patients (30.4%) were male and 29 (36.7%) were splenectomized. The mean ± SD of the best-corrected visual acuity (VA) was 0.960 ± 0.086 decimal, (range: 0.6-1), 0.016 ± 0.046 logMar, (range: 0-0.2). The frequency of patients with VA > 0.1 logMar was 3 (3.8%). The mean intraocular pressure (IOP) was 14.88 ± 3.34 (6-25) mmHg. Fundus abnormalities were observed in 8 patients (10.1%), consisting of increased cup-disk ratio (3.8%), vessel tortuosity (2.5%), retinal pigment epithelium degeneration (2.5%), myelinated nerve fiber layer (1.3%), and internal limiting membrane wrinkling (1.3%). No significant association was observed between fundus abnormalities, VA, or IOP with hematologic parameters (P > 0.05). TDT patients with diabetes mellitus had significantly higher IOP (P = 0.010) but similar frequency of fundus abnormalities with non-diabetic patients (P > 0.05). CONCLUSIONS: The frequency of ocular abnormalities in our patients was lower than the previous reports. The frequency of fundus abnormalities were similar in diabetic and non-diabetic thalassemia patients indicating close monitoring and proper management of the disease and comorbidities in these patients.

Expression of interleukin-6 in ocular surface squamous neoplasia.

PURPOSE: Interleukin-6 (IL-6) is an important cytokine in the cascade of inflammation and cancer progression. The aim of this study was to identify IL-6 expression in ocular surface squamous neoplasia (OSSN) in comparison with non-neoplastic conjunctival tissue. METHODS: Twenty paraffin-embedded tissue sections of conjunctiva from patients with OSSN including conjunctival intraepithelial neoplasia (CIN) in all grades of severity and squamous cell carcinoma (SCC) were assessed by immunohistochemistry staining for IL-6. Twenty non-neoplastic conjunctival sections from age matched patients were selected as the control group. Tissues with more than one focus of inflammatory cell infiltration were excluded from the study. The mean area of positive staining was recorded and the intensity of staining was scored in both groups and compared by statistical methods. RESULTS: The mean staining area in the dysplasia group was significantly more than non-neoplastic conjunctival tissue (63.5±25.96 and 30±15.98 percent respectively; P-value of <0.0001). Nuclear staining was observed in both groups and the difference was not statistically significant. CONCLUSION: IL-6 expressed more in the dysplastic group in compare to non-neoplastic conjunctiva and can therefore be used to diagnose dysplastic state of the conjunctiva; however, in our study, intensity of staining does not correlate with the severity of dysplasia statistically; most probably because of a low sample size in each category. The role of nuclear staining is not clear. Our findings can be an introduction toward targeted treatment of ocular surface neoplasia by the aim of newer anti-IL agents. Further investigation is needed.

The Association of Serum Leptin Level and Anthropometric Measures With the Severity of Diabetic Retinopathy in Type 2 Diabetes Mellitus.

This study was performed to determine the association amongst serum leptin level and anthropometric measures with the severity of Diabetic Retinopathy (DR) in subjects with type 2 Diabetes Mellitus (DM). This case-controlled study was conducted within a one-year period, during year 2016, at outpatient retina ophthalmology clinics of Shiraz, southern Iran. Eighty-three patients with type 2 DM, referring for ophthalmoscopy evaluation, were included. Anthropometric measures, serum leptin level, and baseline laboratory assessment was performed for all subjects. Patients were categorized as group 1, consisting of patients with severe Non-Proliferative Diabetic Retinopathy (severe NPDR) and Proliferative Diabetic Retinopathy (PDR) (n = 44), and group 2, consisting of patients without Diabetic Retinopathy (no DR) or mild/moderate NPDR (n = 39). The serum leptin level and anthropometric measures were compared between the two study groups. The correlation between these variables was also assessed. The mean age of the participants was 59.3 ± 6.9 years old. The two study groups were comparable regarding baseline characteristics. Cases of group 1 had significantly higher Erythrocyte Sedimentation Rate (ESR) (P = 0.049) and Systolic Blood Pressure (P = 0.025) when compared with those of group 2. The serum level of leptin was found to be significantly higher in cases of group 1 when compared to those of group 2 (P = 0.003). However, anthropometric measures, including Body Mass Index (BMI) (P = 0.167), Body Adiposity Index (BAI) (P = 0.061), and Waist to Hip Ratio (WHR) (P = 0.220) were comparable between the two study groups. Serum leptin level was positively correlated with BMI (r = 0.819; P < 0.001) and BAI (r = 0.630; P < 0.001) in group 1. Increased serum levels of leptin were associated with advanced stages of DR in subjects with type 2 DM. Serum leptin level might be a better indicator of the effects of obesity on DR, compared to anthropometric measures (BAI or BMI).

Early Macular Changes after Phacoemulsification in Eyes with High Myopia.

PURPOSE: To evaluate macular changes after cataract surgery in eyes with high myopia. METHODS: This prospective cohort enrolled patients with high myopia (axial length ≥26 mm) who underwent phacoemulsification with intraocular lens implantation. Spectral-domain optical coherence tomography (OCT) scans were obtained at baseline and 2 and 6 months after the operation. Postoperative macular changes on OCT scans were regarded as the main outcome measure. RESULTS: Thirty-four eyes of 31 patients with high myopia were included (age, 60 ± 10 years [mean ± SD]); of these, 14 patients (45.2%) were male. The mean axial length was 27.8 ± 1.5 mm. Epiretinal membrane (one eye, 2.9%), lamellar hole (one eye, 2.9%), myopic foveoschisis (2 eyes, 5.9%), and vitreomacular traction associated with foveoschisis (one eye, 2.9%) were notable findings at baseline examination; no eye showed cystoid macular edema (CME) at this time. At the 2-month examination, three eyes (8.8%) developed CME. At the 6-month follow-up, one eye with CME at 2 months improved, and a new case of CME (5.6%) was detected. The characteristics of epiretinal membrane, lamellar hole, vitreomacular traction, and foveoschisis did not change at the 2- and 6-month examinations and no new cases occurred. CONCLUSION: Uncomplicated phacoemulsification had no significant effect on the prevalence or characteristics of pre-existing macular abnormalities in eyes with high myopia up to 6 months of follow-up. The incidence of CME 2 months after uncomplicated cataract surgery in eyes with high myopia was about 9%.

Subthreshold Continuous Wave Autofluorescence-controlled Laser Treatment of Chronic Central Serous Chorioretinopathy.

PURPOSE: To investigate the therapeutic effect of clinically invisible subthreshold continuous wave autofluorescence-controlled laser treatment on visual acuity and macular status of patients with chronic central serous chorioretinopathy (CSCR). METHODS: In this prospective case series, patients with clinical and fluorescein angiographic (FA) findings of CSCR and chronic visual loss (>6 months) were included. Complete ocular examination, FA, and optical coherence tomography (OCT) tests were performed. Each eye was subjected to a direct laser treatment of leakage points by 532 nm continuous wave low energy laser pulses, which were kept invisible by reducing the power to 70% of the threshold test spot. Considering the lack of visible effect on the retinal pigment epithelium (RPE), the laser effect was monitored by pre- and post -treatment infrared and autofluorescence images. RESULTS: A total of 20 patients were included in this study, of whom 12 patients (9 male and 3 female patients) with an average age of 38 years had complete follow-up (Average: 3.5 months). The mean preoperative visual acuity was 20/80, which improved to 20/40 at the final visit. The mean preoperative central macular thickness (CMT) was 330 µm and the average final CMT in the last OCT test was 188 µm (P = 0.001). CONCLUSION: Subthreshold continuous wave autofluorescence-controlled laser treatment may be a good treatment for chronic CSCR to avoid the risks of retinal damage by clinically suprathreshold laser therapy.

Outcomes of Light Silicone Oil Tamponade for Failed Idiopathic Macular Hole Surgery.

PURPOSE: To study the outcomes of redo macular hole surgery using light silicone oil tamponade. METHODS: In this study, medical charts of consecutive patients who underwent redo pars plana vitrectomy, extended dye-assisted internal limiting membrane peel, and light silicone oil tamponade for failed previous macular hole surgery (from January 2010 to June 2014) were retrospectively reviewed. Best spectacle corrected visual acuity and anatomical closure rates were regarded as outcome measures. RESULTS: Overall, data from 13 patients was recorded and analyzed. The mean (±SD) age of patients was 66 ± 7 years, and four (30.7%) were male. Mean interval between the primary and redo surgeries was 3.7 ± 2.0 months (range, 1 to 8 months). During redo surgeries, 11 (84.6%) subjects underwent additional internal limiting membrane peeling. Mean interval between the redo surgery and silicone oil removal was 5.9 ± 2.1 months (range, 3 to 10 months). After silicone oil removal, patients were followed for 21.8 ± 14.2 months (range, 3 to 51 months). Mean best spectacle corrected visual acuity improved from 20/452 before redo surgery to 20/121 in the last follow-up examination (P < 0.001). Anatomical success was achieved in 11 (84.6%) patients: nine (69.2%) macular holes were closed and two (15.4%) were flat-open. CONCLUSIONS: Redo pars plana vitrectomy with light silicone oil tamponade is an effective method for restoration of macular anatomy and function in patients with persistent macular holes.

Protective effect of methanolic extract of Berberis integerrima Bunge. root on carbon tetrachloride-induced testicular injury in Wistar rats.

BACKGROUND: Tissue protective effect of compounds with antioxidant properties has been demonstrated. The alkaloids found in barberry root are considered as antioxidants. OBJECTIVE: According to barberry protective effects in different tissues, in this study, the protective effect of Berberis integerrima Bge. root )MEBIR) was evaluated against CCl4-induced testicular damages in Wistar rats. MATERIALS AND METHODS: 40 mature male rats were randomly divided into 5 groups: 1: Normal control, 2: Sham: received CCl4 diluted in olive oil (50% v/v; 1ml/kg bw), intraperitoneally, twice a week for 4 weeks, 3 and 4: Sham rats treated with MEBIR (250 and 500 mg/kg bw) for 28 days, 5: Sham rats treated with silymarin (50 mg/kg bw) for 28 days. After 28 days, serum testosterone level, absolute testis weight, catalase activity, malondialdehyde level, and histological parameters were investigated. RESULTS: In the treated rats with MEBIR (250 and 500 mg/kg bw) or silymarin (50 mg/kg bw), there was a significant increase in the absolute testis weight, testosterone level, seminiferous tubules diameter (p<0.001), thickness of the epithelium, tubule differentiation index) p<0.001), spermiogenesis index (p<0.001), the activity of catalase, and a significant decrease in interstitial tissue thickness (p<0.001) and malondialdehyde level in comparison with CCl4-treated group. The effect of the MEBIR at dose of 500 mg/kg bw is more than that of the standard drug, silymarin (50 mg/kg bw). CONCLUSION: From the results, it is suggested that the protective effects of MEBIR is possibly due to antioxidant effects of its bioactive compounds.

Preventive Effects of Aqueous Extract of Berberis integerrima Bge. Root on Liver Injury Induced by Diabetes Mellitus (Type 1) in Rats.

This study was conducted to assessthe preventive effect of aqueous extract of Berberis integerrima Bge. root (AEBIR) on liver damage and oxidative stress induced by diabetes mellitus in rats. Forty male rats were divided into 5 groups as follows: 1- normal (N); 2- normal + barberry (N+B) (they received barberry root extract for 6 weeks); 3- diabetic (D) (they received Streptozotocin (STZ), 65 mg/Kg BW /i.p.); 4- diabetic +barberry before (D+Bb) (they received barberry root extract for 3 weeks before STZ injection and continued for another three weeks); and 5- diabetic + barberry after (D+Ba) (three days after STZ injection, they received barberry root extract for 3 weeks). The experimental groups received barberry root extract (500 mg/Kg bw) intra gastric by gavage for 6 weeks. The treatment of diabetic rats with AEBIR showed a significant decreases(p<0.001) in levels of blood glucose, malondialdehyde (MDA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and total bilirubin while body weight, total protein, superoxide dismutase (SOD), catalase(CAT) and reduced glutathione (GSH) increased (p<0.001) in comparison to diabetic control rats. Consumption of AEBIR in group D+Bb caused significant improvement in all these factors, compared to the group D+Ba. Also in this study, for the first time, we demonstrated that administration of AEBIR before diabetes induction resulted in enhanced amelioration of liver complications compared to the group receiving it after induction, indicating that AEBIR can play a preventive role in such patients.

Diurnal variation of retinal thickness in healthy subjects.

PURPOSE: To investigate diurnal fluctuations in retinal thickness using spectral domain optical coherence tomography (SD-OCT). METHODS: Spectralis SD-OCT was used to obtain data from the right eye of 21 healthy subjects (mean age, 31.3 years) at 7 AM, 1 PM, and 7 PM. For each eye, a full peripapillary retinal nerve fiber layer circular scan and a 19-line horizontal raster scan (6- by 6-mm area) centered on the fovea were performed. RESULTS: Retinal nerve fiber layer thickness was greater at 7 AM or 1 PM than at 7 PM for nasal (79.1 µm [1 PM] vs. 77.6 [7 PM]; p = 0.024), inferior (134.1 [7 AM] vs. 131.9 [7 PM]; p = 0.009), and inferonasal (115.2 [7 AM] vs. 115.6 [1 PM] vs. 112.4 [7 PM]; p < 0.001) subfields. Macular thickness was greater at 7 AM than at 7 PM for inferior 6 mm (290.2 µm [7 AM] vs. 287.8 [7 PM]; p < 0.001) ETDRS (Early Treatment Diabetic Retinopathy Study) subfield. Macular volume was greater at 7 AM than at 7 PM for nasal 3 mm (0.541 mm vs. 0.538; p = 0.028) and inferior 6 mm (1.538 vs. 1.525; p < 0.001) ETDRS subfields. The remaining studied areas did not show any significant change throughout the day. CONCLUSIONS: The Spectralis SD-OCT retinal thickness measurements showed a small but statistically significant diurnal variation in nasal and inferior subfields toward smaller values in the evening. However, the overall change is close to the instrument's resolution and repeatability.

Antihyperglycemic and Antihyperlipidemic Effects of Fruit Aqueous Extract of Berberis integerrima Bge. in Streptozotocin-induced Diabetic Rats.

Use of medicinal plants for attenuation of hyperglycemia and restoration of lipids disorder to normal level is clinically very important. The aim of present study was to evaluate the effects of Berberis integerrima Bge. fruit aqueous extract (BIFAE) on blood glucose and lipid profile in streptozotocin (STZ) - induced diabetic rats. The STZ-induced diabetic rats were treated by fruit aqueous extract of Berberis integerrima Bge. at doses (250 and 500 mg/Kg bw) and glibenclamide (0.6 mg/Kg bw) for 42 days by gavage. Blood glucose levels and body weights of rats were measured on weeks 0, 2, 4 and 6. Total lipid levels were determined in normal and STZ-induced diabetic rats after administration of the BIFAE and glibenclamide for 42 days. STZ-induced diabetic rats showed a significant (P<0.001) increases in the levels of blood glucose, triglycerides (TG), total cholesterol (TC), low density lipoprotein LDL-cholesterol (LDL-C) while body weight and high density lipoprotein HDL-cholesterolan (HDL-C) were significantly(P<0.001) decreased compared to normal rats. Daily administration of BIFAE did not possess the hypoglycemic and hypolipidaemic activity in STZ- diabetic rats during 6-week treatment period. Results indicate the usage of BIFAE in traditional medicine for the treatment of diabetes may need more investigation.

Effects of Aqueous Extract of Berberis integerrima Root on Some Physiological Parameters in Streptozotocin-Induced Diabetic Rats.

Diabetes mellitus is a common endocrine disorder. Anti-diabetic agents from natural and synthetic sources are available for the treatment of this disease. Berberis integerrima is a medicinal shrub used in conventional therapy for a number of diseases. The aim of the present study was to investigate the effects of aqueous extract of Berberis integerrima root (AEBI) on some physiological parameters in normal and streptozotocin-induced (STZ-induced) diabetic male Wistar rats. STZ-induced diabetic rats showed significant increases in the levels of blood glucose, triglycerides (TG), total cholesterol (TC), low density lipoprotein LDL-cholesterol (LDL-C), creatinine (Cr), urea, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin while body weight, high density lipoprotein HDL-cholesterol (HDL-C) and total protein levels were significantly decreased compared to normal rats. Treatment of diabetic rats with different doses of aqueous extract of Berberis integerrima root (250 and 500 mg/Kg bw) resulted in a significant decrease in blood glucose, triglycerides, cholesterol, LDL-cholesterol, ALT, AST, ALP, total bilirubin, creatinine and urea while HDL-cholesterol and total protein levels were markedly increased after six weeks compared to untreated diabetic rats. The effects of the AEBI at dose of 500 mg/Kg in all parameters except blood glucose (similar) is more than to the standard drug, glibenclamide (0.6 mg/Kg, p.o.). The results of this study indicate that the tested aqueous extract of Berberis integerrima root possesses hypoglycemic, hypolipidemic and antioxidant effects in STZ-induced diabetic rats.

Aqueous extract of Berberis integerrima root improves renal dysfunction in streptozotocin induced diabetic rats.

OBJECTIVE: Barberry root extract contains various alkaloids that are considered as antioxidants. Beneficial effect of aqueous extract of Berberis integerrima root (AEBIR) was evaluated for renal function in diabetic rats induced by STZ. MATERIAL AND METHODS: Diabetes was induced by i.p. injection of streptozotocin (65 mg/kg bw) to rats, after 15 h of fasting. Diabetic rats were randomly grouped and treated daily with AEBIR and glibenclamide by gavage for 42 days. After 6 weeks of study, all the rats were sacrificed and some biochemical parameters of serum and urine were measured and their kidneys tissues were processed for light microscopy. RESULTS: Streptozotocin induced a significant rise in fasting blood glucose, serum creatinine, blood urea nitrogen, urine glucose, urine protein, urine albumin, and water intake and a significant decrease in body weight, serum protein, urine urea, and urine creatinine. There was a significant restoration of these parameters to near normal after administration of the AEBIR and also by glibenclamide (0.6 mg/kg bw). The activity of the extract at dose of 500 mg/kg in all parameters except blood glucose and urine glucose was more than that of the standard drug, glibenclamide (0.6 mg/kg, p.o.). Histopathological changes of kidney samples were comparable with respective control. CONCLUSION: These results suggested that aqueous extract of Berberis Integerrima root improves renal dysfunction in streptozotocin-induced diabetic rats through controlling blood glucose and renal protective effects.

Effect of macular edema on optical coherence tomography signal strength.

PURPOSE: The purpose of this study was to examine the effect of macular edema (ME) on Stratus optical coherence tomography (OCT) (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) signal strength (SS). METHODS: Part 1: Macular OCT was performed in 57 eyes with ME, at 2 different time points with different degrees of ME. The relationships between SS change and change in center point thickness and total macular volume in two scans were examined. Part 2: In 54 eyes with ME, Stratus OCT examinations with macular thickness mapping and retinal nerve fiber layer analysis protocols were performed. The paired values of SS obtained with two scan protocols were compared. The relationship between SS difference between two test protocols with center point thickness and total macular volume was evaluated. RESULTS: Part 1: There was a significant correlation between SS change and the change in center point thickness and total macular volume in 2 consecutive scans. Part 2: Maximum SS obtained during macular OCT examination was significantly less than that obtained during retinal nerve fiber layer OCT. Significant correlations were observed between the difference in SS obtained in two scan protocols and center point thickness as well as total macular volume. CONCLUSION: Macular edema decreases macular OCT SS. In patients with ME, SS obtained during macular OCT examination was significantly lower than that obtained during retinal nerve fiber layer OCT examination.