14 Clinical Trials for Various Conditions
This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.
This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.
ABBV-RGX-314 is being developed as a novel, potential one-time gene therapy treatment for the treatment of Diabetic Retinopathy (DR) with and without Center-Involved Diabetic Macular Edema (CI-DME). DR is a chronic and progressive complication of diabetes mellitus. It is a sight-threatening disease characterized in the early stages by neuronal and vascular dysfunction in the retina, and later by neovascularization that leads to further deterioration of functional vision. Despite the availability of current treatments, diabetic retinopathy remains the leading cause of vision loss in working-age adults, those between the ages of 20 and 74. Existing treatment with anti-VEGF agents, although shown to be effective, are limited by short therapeutic half-lives, which then require frequent intravitreal injections over the patient's lifetime, resulting in increased risk of associated adverse events and significant treatment burden. Due to the burden of treatment, patients often do not closely adhere to treatment regimens and experience sub-optimal outcomes and a decline in vision.
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.
Results from large clinical trials demonstrate a strong association between lipid abnormalities and progression of the most common microvascular complication, diabetic retinopathy (DR). We found that activation of a master regulator of cholesterol metabolism, the nuclear hormone receptors liver X receptors (LXRα/LXRβ), prevents DR in rodent models. In this application, we seek to understand the mechanisms responsible for the beneficial effects of LXR agonists on retina and on bone marrow (BM) to preserve the function of reparative cells while reducing inflammatory cell.
This research study is being conducted to improve eye care by using artificial intelligence (AI) to make diabetic eye screenings faster and more accessible. AI technology mimics human decision-making, enabling computers and systems to analyze medication information. Specifically for this screening, AI examines digital images of the eye and based on that information, may identify if a participant has diabetic retinopathy. It can assist doctors in making decisions about a participant's diagnosis, treatment or care plans to improve patient care. This is a collaboration between San Ysidro Health (SYHealth), University of California, San Diego (UC San Diego), and Eyenuk. The Kaiser Permanente Augmented Intelligence in Medicine and Healthcare Initiative (AIM-HI) awarded SYHealth funds to demonstrate the value of AI technologies in diverse, real-world settings.
The goal of this clinical trial is to learn about the performance of the AEYE-DS Software Device to automatically detect more than mild Diabetic Retinopathy (mtmDR) in adult participants diagnosed with Diabetic Mellitus (DM) using fundoscopic images of the eyes. The main question it aims to answer is if the software is effective in diagnosing more than mild Diabetic Retinopathy (mtmDR) in patients with known diabetes using digital funduscopic images, acquired from each of the participating fundoscopy devices and based on one macula centered image per eye. Participants: * will have an eye exam in which photographic images of each eye will be taken by a novice operator, using four different FDA approved/registered fundoscopy cameras. These images will be sent to and analyzed by the AEYE-DS software device. * will have additional eye imaging taken using a different FDA approved desktop camera system by a professional ophthalmic photographer. These images will be sent to an independent reading center for analysis. * will have dilation drops put in their eyes (either during or after the imaging with the fundoscopy cameras), wait about 30 minutes for the pupils to dilate and continue the eye imaging exams. The outcome results with the AEYE-DS Software will be compared to the analysis of the eye images processed by the reading center to see if the investigational software device was accurate in its diagnosis.
This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR without center involved-diabetic macular edema (CI-DME) in which they received SCS administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.
The study will explore the impact of photobiomodulation (PBM), pulsating at frequencies of red (660nm) and near-infrared (810nm)(NIR), concurrent with a ketogenic dietary protocol (serum ketones @ .5 - 2.0 mmol/L) to mediate vascular features of diabetic retinopathy (DR), diabetic macular edema (DME), age-related macular degeneration (AMD), mid-peripheral drusens, visual acuity and retinal disorders. Red and near-infrared light via light-emitting diode (LED) treatment promotes retinal healing and improves visual acuity by augmenting cellular energy metabolism, enhancing mitochondrial function, increasing cytochrome C oxidase activity, stimulating antioxidant protective pathways and promoting cell survival. LED therapy directly benefits neurons in the retina, the lateral geniculate nucleus and the visual cortex; likewise, a ketogenic dietary protocol shows metabolic and neuro-modulatory benefits within the CNS, most notably as treatment for refractory epilepsy. Photobiomodulation has been approved as a non-significant risk (NSR) modality for the treatment of eye disorders.
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.
In this study, markers of oxidative stress will be measured in the aqueous humour of stargardt disease, age related macular degeneration and diabetic retinopathy patients compared to controls.
This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for enrollment upon completion of the end of study visit in the parent study.
A Phase 2, Multi-Center, Randomized, Double-Masked\*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema \[INFINITY\] \*sponsor unmasked for enhanced safety monitoring as of May 2021
This study will test whether a new non-invasive technique can quickly and precisely measure retinal metabolism (the amount of energy retinal cells use). The retina is the part of the eye that sends information to the brain. Participants in current NEI studies who have age-related macular degeneration (AMD), diabetic retinopathy, or von Hippel-Landau disease may be eligible for this study. Healthy volunteers will participate as controls. Patients with AMD must be 60 years of age or older; those with VHL disease or diabetic retinopathy must be 18 or older. Participants undergo the tests and procedures required in the NEI study in which they previously enrolled. In addition, for the current study, they undergo metabolic mapping. For this procedure, the subject's eyes are dilated, and different amounts of low-level light are shone into the eye to see how different cells respond with changes in metabolism. Measurements are taken while the subject breathes room air and while he or she breathes medical grade oxygen for about 1 minute. The entire procedure takes about 15 minutes.