Active clinical trials for "Retinal Diseases"

The purpose of this study is to correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume.

Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants. Inflammation, hypoxia-ischemia, free oxygen radical formation and excitotoxicity are all known pathogenic mechanisms that mediate this injury. Erythropoietin (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries. During the past decade, recombinant human Epo (rhEpo) has been widely used in preterm infants to prevent or treat the anemia of prematurity, in general, rhEpo has been considered to be safe and well tolerated in preterm infants. EPO was considered not capable of passing through blood-brain-barrier at low dose. Evidence from animal experiments reveals that rhEpo must be given in high doses at the beginning or within a short (up to 6 hours), critical time period after the onset of brain injury to achieve a significant neuroprotective effect. A recent study using high-dose rhEpo (3000 U rhEpo/kg body weight at birth) for neuroprotection in very preterm infants revealed that no signs of adverse effects of early high-dose rhEpo treatment in very preterm infants were identified. Contrary to this, a recent study in PVL of a rat model revealed that using a low dose rhEpo (50-100 U/kg) was effective in the treatment of brain damage induced by hypoxia-ischemia and did not affect normal oligodendrocyte maturity. On this basis, the researchers intent to investigate (1) whether low-dose rhEpo (100 U/kg) or high-dose rhEpo (3,000 U/kg) given to very preterm infants (gestation age < 32 weeks) immediately after birth and subsequently during the first 2 days is safe and possesses neuroprotective properties;(2) whether there are gender differences in response to the hypoxia-ischemic insult and EPO treatment; (3)the pharmacokinetics of low dose and high dose rhEPO. Very preterm infants with gestational age of < 32 weeks and admitted to the NICU are eligible for enrollment.

Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in detecting inflammation in these patients. The aim of this study was to determine the effects of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.

Diabetes affects 30.3 million people or 9.3% of the population of the United States. Results of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients have some degree of diabetic retinopathy (DR) and that as many as 8% have severe, vision-threatening forms of DR. Early laser photocoagulation in high-risk proliferative diabetic retinopathy (PDR) has been shown to decrease the relative risk of vision loss by as much as 52%. Injections of anti-VEGF agents preserve and improve vision in people with PDR and/or diabetic macular edema. Despite effective treatment however, tens of thousands of people with diabetes are going blind each year largely because they don't undergo annual screening for retinopathy. Currently, less than 50%-60% of people with diabetes have a yearly eye exam and there may not be enough eye specialists to see the balance. The IDx-DR System is intended for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.

Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels higher than they should be. In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. This damage results in small outpouchings of the vessel lumens leading to rupture. At the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. In these early stages of DR current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure. Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD), a condition in which the kidneys become damaged and do not work as they should. These participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels To learn more about the effect of Finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. All male and female participants included in this study are at least 18 years.

The purpose of this study is to evaluate the combined effects of diabetes self-management education (DSME) and nutritional supplementation on visual function and retinopathy incidence & progression in patients with type 1 diabetes, type 2 diabetes and pre-diabetes.

Observational, comparative, cross-sectional study

This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2 diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB. Moreover, the study evaluates the possible effect of RYGB on diabetic microvascular complications such as nephropathy and retinopathy. Finally, the study provides insight into the factors influencing glucose-insulin homeostasis after RYGB, including altered microbiota diversity and bile acid levels.

The study is an Observational, Phase 0 designed to establish that the risk for diabetic retinopathy assigned by the RiskAnalyzer improves the reading accuracy and consistency of any reader and it decreases the inter-reader variability. Objectives: Objectives one, two, and three are arranged chronologically and in an increasing level of complexity as a three tiered approach to support the primary and secondary endpoint of the trial. Objective one is to test fully each system components of the study limited to a single site. Objective two is to evaluate the efficacy of the RiskAnalyzer to assign the risk of Diabetic Retinopathy in comparison to the gold standard. Objective three is to demonstrate that the reader's accuracy in grading images is improved when risk levels assigned by the RiskAnalyzer are made available to the reader while performing the grading of the images which is the primary endpoint of the trial Methods and Research Design: A network of clinical study sites will be established to meet the required number of cases needed as calculated by statistical analysis. Male and Female Subjects between the ages of 18-65 who are either pre-diabetic or diabetics will be eligible for participation in this study. Subjects will be recruited, consented, photographed and their images graded by two trained readers and analyzed by the RiskAnalyzer . The risk levels that are obtained from the RiskAnalyzer will be compared to the current gold standard practice, manual grading of each case by a reader. Data collected during this clinical trial will be reported to the referring physician in the form of a retinal screening report completed and signed by a licensed Ophthalmic professional and delivered to their attending physician. Risk levels for diabetic retinopathy obtained by use of the RiskAnalyzer will not be given to the attending physician under any circumstances in order to preserve standard of care for the patient. The sensitivity, specificity, receiver operating characteristic (ROC), and data flow process of the RiskAnalyzer, retinal image reading system will be analyzed and based on the current gold standard of a human reader. This study is a three-aims study, 24 month in length, prospective, case-only study of the performance of the RiskAnalyzer. The risk levels obtained from the RiskAnalyzer are not made visible, i.e. are not unmasked to either of the two readers. In year two, the risk levels obtained from the RiskAnalyzer for half of the studies are unmasked to the two readers while grading the image. Access to all study data and processes follows a role-based design. The clinical staff will have access only to clinical data but not the technical data. The technical team will have access to the technical data only but not the clinical data. The study coordinator will have access to all data. The use of computers will adhere to the Guidance for Industry Computerized Systems Used in Clinical Investigations and applicable sections of 21 CFRs part 11.

Some studies have recently shown that the concentration of erythropoietin in the vitreous humor of diabetic patients suffering from diabetic retinopathy is higher than non-diabetic patients. It was reported a higher concentration of erythropoietin in vitreous humor than blood, indicating a local production. In some cases it was also found a positive association between concentrations of Erythropoietin and Vascular Endothelial Growth Factor (VEGF). Both of these factors, erythropoietin and VEGF, show important angiogenic activity and may play a role in the development of diabetic retinopathy. This study enrolled type 2 diabetic patients with PDR who had to undergo vitrectomy during the period May 2011-January 2012 at the Unit of Ophthalmology, A.O. Civil Hospital and University of Brescia. Inclusion criteria were the following: type 2 diabetes, age greater than 18 years, and PDR; exclusion criteria were: age less than 18 years, type 1 diabetes, initial DR, PDR patients not requiring surgery, previous vitrectomy in the eye under examination or other ophthalmic surgery or laser therapy within the previous 3 months. Non-diabetic patients who underwent vitrectomy for macular hole or pucker represented the control group (CTRLs); their inclusion criteria were: age greater than 18 years and the presence of macular pucker or macular hole requiring vitrectomy. Exclusion criteria were: age less than 18 years, diagnosis of diabetes mellitus, and previous vitrectomy in the eye under examination or other ophthalmic surgery or laser therapy within the previous 3 months. All patients underwent a complete ophthalmologic examination (visual acuity, slit lamp, tonometry, fluorescein retinal angiography, and optical coherence tomography -OCT-). Informed consent was obtained from all patients after a detailed description of the aims and procedures of the study. The following data were recorded for each patient: Population: age (years), sex (M/F); Clinical: diabetes (Absent or Type 2); time since initial diagnosis of diabetes (years); type of therapy for DM: diet, oral hypoglycaemic agents, mixed (oral agents and insulin, insulin); hypertension (defined as systolic blood pressure > 140 and diastolic blood pressure > 90 mmHg or on antihypertensive drugs); current (Yes/No) antihypertensive therapy; use of angiotensin II receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACE-i); presence of hypercholesterolaemia, comorbidities, therapy with statins (Yes/No), anticoagulants (Yes/No), antiplatelet therapy (Yes/No); other therapies performed, smoking (non-smoker, active smoker); complications of diabetes mellitus present at the time of evaluation (heart disease, nephropathy, neuropathy); Ocular: eye (OD/OS); visual acuity; presence and grade of diabetic retinopathy; presence of emovitreo; presence of diabetic macular oedema; presence of cataract or lens implant; intervention with phacoemulsification during vitrectomy; presence of retinal diseases, or any other concomitant eye diseases; performance of previous retinal laser therapy, intravitreal injection of Avastin before the vitrectomy; Biochemical: Haemoglobin (g/dL); glucose (mg/dL); glycated haemoglobin (%); platelets (N/mmc); creatinine (mg/dL); albuminuria (mg/day), creatinine clearance (mL/min), calculated by the Modification of Diet in Renal Disease (MDRD) formula; total cholesterol (mg/dL); HDL and LDL; triglycerides (mg/dL). All patients underwent a 23- or 25-gauge pars plana vitrectomy. The primary outcome of the study was the measurement of EPO and VEGF concentrations in serum and vitreous and aqueous humor. Blood samples, taken before surgery, were centrifuged at 3000 rpm for 10 minutes to separate the serum fraction, which was stored at -80°C. Aqueous and vitreous humor were taken during the surgery and immediately frozen at -80°C. Both EPO and VEGF concentrations were measured in serum and vitreous humor; however, owing to the small amount of sample, only EPO concentrations were determined in aqueous humor. EPO was assayed by radioimmunoassay (Immulite EPO 200, Siemens), with the lowest detection limit of 1.0 mIU/mL. VEGF was assayed by ELISA (Human VEGF Immunoassay, R & D Systems Europe, Abingdon, UK) with a lower limit of detection of 10.0 pg/mL. VEGF concentrations below the lower limit of detection were set to 5 pg/mL to perform statistical analysis. VEGF values above 2000 pg/mL were set to 2500 pg/mL; statistical tests were also performed after deleting the data above 2000 pg/mL.