The objective of the study is to evaluate the safety and efficacy of the JenaValve Pericardial TAVR system when treating patients with aortic regurgitation. Aortic Regurgitation is a condition that develops when the heart's aortic valve does close tightly, therefore the blood leaks back into the heart chamber. The JenaValve Pericardial TAVR system will…
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of…
This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and delivery of a self-…
Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) requires the need for treatment. This is a study that is collecting safety and…
This study will develop a data registry of patients diagnosed with uveal melanoma (UM). This registry will provide data that will be used to support the development of novel therapies for this disease. In this study, we are focused on trying to better understand how uveal melanoma behaves and how it is treated at different medical centers around the country.
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement…
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment…
The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in individuals with geographic atrophy secondary to dry age-related macular degeneration (AMD) who qualify, based on genetic testing.
The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening…
This is a Phase I study of a weekly intra-patient escalation dose regimen with IMCgp100 in patients with metastatic uveal melanoma (mUM). To help decide whether or not patients can take part in a research study looking at a new form of treatment for advanced uveal melanoma, their blood need to first be tested to determine their Human Leukocyte Antigen (HLA…
Glaucoma is a given name of a group of diseases that affect the retinal ganglion cells in the eye and the optic nerve. Glaucoma cause degeneration of the retinal ganglion cells in the retina and their projections (axons) that form the optic nerve. Retinal ganglion cells and their axons transmit all of our vision information from the eye to the brain through…
The purpose of the treatment part of the study is to find out what effects drug crizotinib has, good and/or bad on people with "high risk" uveal melanoma after surgery or radiation for the eye. It is thought that giving crizotinib to patients with "high risk" uveal melanoma can lower the chance the cancer will come back. Uveal melanoma…
The abicipar is an injectable medication stored as a liquid in a single-use glass vial for delivery into the back of the eye. The active component is a protein drug that was made using bioengineering technology. It was designed to bind to and inactivate a protein called Vascular Endothelial GrowthFactor (VEGF) that plays an important role in causing AMD.…
The purpose of this study is evaluate the benefits and safety of using the combination of drugs, AEB071 and BYL719 to treat patients with an advanced form of uveal melanoma. The study will have two parts. The first part twill test different dose levels of each drug.Once the highest safe dose level is found, another group of patients will be treated at that…
Macular degeneration is a progressive eye disease that damages the macula. The macula is the part of the eye that is responsible for central vision, which is needed to perform straight-ahead activities, such as reading, driving, or watching TV. This research is being conducted to learn about the safety and efficacy (how effectively the study drug works) of…
This study is for patients with Glaucoma. The purpose of this study is to investigate the safety and effectiveness of a study drug called Bimatoprost Sustained Release (SR) compared to treatment with eye drug Timolol. The Bimatoprost SR is an implant that is very small, is biodegradable (dissolves naturally in the body), and contains the bimatoprost drug.
You are invited to join voluntarily in a clinical research study to find out if the drug LXS196 alone or in combination with HDM201 is safe and has beneficial effects in people who have metastatic uveal melanoma. The purpose of this study is to determine the highest dose of LXS196 that can be given safely without unacceptable side effects as a single drug…
Stargardt macular degeneration isa genetic condition, which in mostcases causes vision loss early in lifeand leads to legal blindness. Thereis currently no FDA-approvedtreatment.This trial will evaluate the safetyand effects of ALK-001, a newpotential drug treatment, on theprogression of Stargardt disease.ALK-001 is a capsule administereddaily by mouth.This…
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…
This research study is being done to see if the study drug, IMCgp100, works and is safe as treatment for subjects with uveal melanoma who also test positive for HLA-A*0201. In this study IMCgp100 will be compared to three standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug), or pembrolizumab (an immunotherapy drug).…
The purpose of this study is to find out what effects, good and/or bad, intermittent dosing of the medication Selumetinib will have on you and your uveal melanoma. Selumetinib is a medication that blocks (or turns off) MEK, a protein activated in some uveal melanoma cells. Selumetinib is a MEK inhibitor. Blocking MEK may stop your cancer from growing.