Active clinical trials for "Retinal Diseases"

Aim To investigate repeatability and stability of the six OTH-related Bulbicam tests in patients suffering from a) Diabetic retinopathy (DR), b) Age related macular degeneration (AMD) and matched healthy controls (HC). To compare Bulbicam and the Standard Method on measurements of Visual Field and Pupil To contribute to the establishment of normal range for DR and AMD patients with different degree in the disease development related to the Bulbicam tests. To contribute to the establishment of normal range for a normal population without eye-disease related to the Bulbicam tests. Study population The study consists of the following three study populations: 1) Patients suffering from DR of both genders above 18 years of age with different disease degree; 2) Patients suffering from AMD of both genders above 18 years of age with different disease degree; 3) Gender- and age-matched HC without any eye diseases. Study procedure Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation.

Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-vascular endothelial growth factor therapy drugs. In the current study, the primary aim is to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

The goal of this research project is to identify the long-term outcome of neurodevelopment in patients with retinopathy of prematurity(ROP) and the treatment of anti-vascular endothelial growth factor (VEGF) such as intravitreal injection of bevacizumab (IVB), ranibizumab, or aflibercept.Investigators propose this study hopefully to have a better understanding of the long-term safety of anti-VEGF on the treatment of ROP. Studies in both animalsand humans have found evidence of systemic bevacizumab exposure after IVB. In an animal study, IVB at an early age could result in more systemic bevacizumab exposure. Our study has further shown that VEGF levels in ROP infants were depressed for 8 weeks after IVB. VEGF plays an important role in neurogenesis in embryos and preterm newborns. In previous reports, blocking VEGF-A expression has been shown to impair brain vascularization and lead to neuron apoptosis in the retina. In addition, VEGF has been found to be lower in preterm pups compared to term pups, and this has been proposed to relate to the neurodevelopmental delay and reduced growth of the cerebral cortex in premature infants. Since neurogenesis may continue in the third trimester, further inhibition of serum VEGF in preterm newborns may have long-term effects on the development of the central nervous system and other systems. Currently, most studies reported neurodevelopmental outcomes in anti-VEGF treated premature infants before 2 years of age, and only one study reported 5 year outcomes. Our recent study also found that the neurodevelopmental outcomes at the mean age of 1.52 ± 0.59 years after birth were similar between ROP patients who did not require treatment and ROP patients with IVB treatment. Unfortunately, the value of early assessments of cognition in predicting cognitive functioning at school age and older is questionable.Many developmental deficits in cognition, emotional and behavioral development, and social adaptive functioning may emerge at older ages in the absence of neurodevelopmental impairment in toddlerhood. Visuomotor function deficit are also noted at school age in children who had normal development at 3 years of age. The above studies demonstrate a need for longer follow-up of the preterm infants to fully comprehend their neurodevelopmental outcomes. To our knowledge, currently there are no reports of neurodevelopmental outcomes in anti-VEGF treated premature infants beyond 5 years of age. Therefore, investigators propose this study hopefully to have a better understanding of the long-term safety of anti-VEGF on the treatment of ROP. This study will aim at (1) Understanding the long-term neurodevelopmental outcomes of intravitreal injection of anti-VEGF comparing to standard laser treatment for ROP in premature infants. (2) Compare the long-term neurodevelopmental outcomes in premature infants with ROP treated by different anti-VEGF agents. (3) Analysis the long-term ocular morphological and functional outcomes in premature infants with ROP with prior treatments. Investigators plan to recruit patients from our previous ROP cohort, who now aged 3 to12-years-old. Thepatients will be divided to six groups:premature without ROP (Group 0); ROP without treatment (Group 1); ROP with laser photocoagulation treatment (Group 2); ROP with anti-VEGF treatment (Group 3); ROP with laser photocoagulation + anti-VEGF treatment (Group 4); Fullterm (Group 5).Serialneurodevelopmental tests, such as Chinese Child Development Inventory (CCDI), Child Behavior Checklist (CBCL), The Berry-Buktenica Developmental Test of Visual-Motor Integration, Bayley Scales of Infant Development, Wechsler children's intelligence test- fourth editionand other neurocognitive tests and questionnaires, will be performed yearly in all patients. The detailed visual tests, such as best-corrected visual acuity, slit lamp examination, indirect ophthalmoscopy,and optical coherence tomography (OCT) will be performed every 6 months. Main outcome measures will be neurodevelopmental outcomes. The neurodevelopmental outcomes will be analyzed longitudinally and in the cross-section fashion. These outcomes will be compared between the five groups, and in the subgroup analysis. Secondary outcomes will include ocular morphological and functional results of these children. Finally, the correlation of ocular resultswith neurodevelopment outcomes will be analyzed. Investigators are fortunate to have the opportunity of following a longitudinal ROP cohort and monitor their long-term outcomes. In the long-term, this studywill improve understanding the long-term safety of anti-VEGF treatment for ROP, which is a heatedly debated topic. Investigators will also have a better knowledge which anti-VEGF might be safer than the other. Understanding these facts will help us to come up with a better treatment strategy for ROP in the future.

The goal of this observational study is to analyse and compare Diabetic Retinopathy severity level using 30º ETDRS 7-fields and Wide-field Imaging techniques using Clarus 500 (Carl Zeiss Meditech Inc., Dublin, USA) and Optos (Optos, Dunfermline, UK) in diabetic patients with mild to moderate diabetic retinopathy. The main questions it aims to answer are: 1. To compare the Clarus 500TM wide-field imaging technique with the ETDRS 7-fields method in the assessment of DR severity level using the ETDRS DRSS.2. To compare the two wide-field imaging techniques (Clarus 500TM vs OptosTM) in the assessment of DR severity level using the ETDRS DRSS.3. To evaluate the peripheral area imaged by the wide-field Clarus 500TM and OptosTM to characterize DR lesions distribution (predominantly observed within or outside the ETDRS 7-fields) and severity (according to the ETDRS standard photos).4. To determine the relevance and frequency of DR PPL, located outside the ETDRS 7-fields area, and to explore PPL occurrence in different DR severity levels. Participants will undergo a non-invasive ophthalmological examination, which includes BCVA, 7-fields CFP and UWF FP to assess ETDRS DRSS level.

Research Objective: The primary objective is to investigate the short-term effects of repetitive low-intensity red light therapy on the fundus of the eyes of underage individuals with myopia. Research Design: This experiment employs a prospective, single-center, randomized, controlled clinical research design. Primary Outcome: Changes in macular sensitivity (microperimetry). Recruitment and Participant Information: The study population consists of individuals aged 7 to 17 years old. It is anticipated that there will be 35 participants in both the control group and the experimental group. Trial Location: Zhongshan Ophthalmic Center, Sun Yat-sen University. Contact Information: Shuyu Chen, +190805155537, chenshuyu980916@163.com.

The purpose of the study is to determine whether HG004 as gene therapy is safe and effective for the treatment of Leber Congenital Amaurosis caused by mutations in RPE65 gene.

Retinopathy of Prematurity (ROP) is a vascular disease affecting the retinas (back of the eye) of low birth weight infants. Although it can be treated effectively if diagnosed early, it continues to be a leading cause of childhood blindness in the United States and throughout the world. The investigators feel that this study will result in specific knowledge discovery about ROP, as well as general knowledge about how image-based data and genetic data can be combined to better understand clinical disease. Participants will be recruited from the neonatal intensive care unit (NICU) at OHSU, along with 4 collaborating institutions (William Beaumont Hospital, Stanford University, University of Illinois Chicago and University of Utah). Hospitalized infants who receive ROP screening examinations for routine care will be eligible for this study, and will be offered the opportunity to participate. Subjects who provide informed consent will have clinical data from routine care collected along with demographic characteristics, results from routine ROP screening examinations, presence of systemic disease or risk factors. Retinal photographs will be taken during these routine eye exams, using a commercially-available camera that has been FDA-cleared for taking pictures from retinas of premature infants. These retinal pictures do not contain any identifiable patient information, and are taken as routine standard of care. The long-term goal of this research is to establish a quantitative framework for retinopathy of prematurity (ROP) care based on clinical, imaging, genetic, and informatics principles. The investigators have previously recruited and rigorously phenotyped and genotyped a large study cohort, including implementation of a novel reference standard diagnosis; and built a world-class research consortium for image, genetic, and bioinformatics analysis.

Diabetic retinopathy (DR) is a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment threshold. The recently developed OCT angiography (OCTA) provides dye-less, injection-free, three-dimensional images of the retinal and choroidal circulation with high capillary contrast. Not only is it safer, faster, and less expensive than conventional dye-based angiography, OCTA provides the potential of giving clinicians objective tools for determining severity of disease by detecting and quantifying NV and non-perfusion.

In industrialized nations diabetic retinopathy(DR) is the most frequent microvascular complication of type 2 diabetes mellitus and the leading cause of visual impairment and blindness in the working-age population. The well-accepted strategy for prevention and treatment of diabetic eye complications focused on confirmed diabetic retinopathy, diabetic macular edema, cataract, etc, and there was no definitive therapy for preclinical central visual acuity (CVA) impairment, mainly because of its unknown pathogenesis. In our previous population-based study, the prevalence rate of early CVA impairment was as high as 9.1%, and that obviously limits the effects of diabetic eye diseases prevention and early-stage treatment strategy. Of note, the choriocapillaris is the only route for metabolic exchange in the retina within the foveal avascular zone, it was speculated that early CVA impairment is related to diabetic choroidopathy (DC). Recent research shows that the decreased macular choriocapillaris vessel density (MCVD) in diabetic eye ,which indicating early ischemia, is already present before diabetic macular edema can be observed; we have observed subfoveal choroidal thickness (SFCT) decreased significantly in the early CVA impairment patients. However, up til now, there was no epidemiology report on early CVA impairment in Chinese diabetes population. In the present study, we plan to conduct a 10-year perspective cohort observation of 2217 Chinese type 2 diabetic residents without diabetic retinopathy, diabetic macular edema, cataract and other vision impairing diseases, trying to find out related physical and biochemical risk factors. The results will facilitate discriminating high risk groups of early CVA impairment in diabetic patients. In the same time, a quantitative relationship between SFCT change, MCVD change and CVA change will be established. This study will demonstrate the role of DC in the occurrence of preclinical CVA impairment, and provide important theoretic evidence of blocking agents which target on DC.

The development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. This late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (ROP). Among the various factors influencing retinal vascular development, the tissue content of omega-3 polyunsaturated fatty acids (PUFAs) appears to be a crucial element. In a previous project, OMEGA-ROP, we showed a difference in the blood bioavailability of omega-3 PUFAs in infants born at less than 28 weeks of amenorrhea who develop ROP compared to healthy newborns with no retinopathy. This study also showed that mothers experienced variations in the blood levels of omega-3 PUFAs that were contrary to the types of variations observed in their children. This suggests a sequestration of omega-3 PUFAs in the mothers of children who will develop ROP. This new project aims to better understand the underlying molecular mechanisms by studying the expression levels of placental fatty acid receptors in relation to the development of ROP in newborns.