View clinical trials related to Macular Degeneration.
Filter by:Age related macular degeneration (AMD) is the leading cause of vision loss in individuals over age 60. AMD is classified as wet and dry. Wet AMD constitutes 10 to 15% of all cases of AMD and occurs when an abnormal blood vessel grows in or under the retina leading to central vision loss. Wet AMD is successfully treated with injections in the eye on a monthly basis that stop the blood vessel from growing and leaking. The most common form of AMD is the dry variant or dry AMD that affects 85 to 90% of all patients with AMD. In dry AMD, there is loss of retinal pigment, formation of deposits called drusen, and loss of the vessels in a layer of the retina called the choriocapillaris. In the most severe forms of dry AMD there is loss of retinal tissue called geographic atrophy. Over time retinal tissue degenerates in the area responsible for central vision leading to vision loss leading to legal blindness. Currently no treatment for dry AMD exists so that there is a significant unmet need in patients with this ocular disease. Recently, evidence has implicated an overactive inflammatory cascade called the complement system as playing a pivotal role in the development of dry AMD. The complement cascade consists of 3 arms that converge to form a pore-like complex on the surface of cells called the membrane attack complex (MAC). Accumulation of MAC on cell surfaces leads to cell damage and death causing the clinical findings seen in AMD. Normal cells within the human body produce a protein on their cell surfaces called CD59 that blocks the MAC from forming. In AMD, the complement cascade is upregulated and leads to more MAC formation than the body can protect itself against leading to cell destruction. AAVCAGsCD59, an ocular gene therapy product that is injected in to the eye in the physician's office, causes normal retinal cells to increase the expression of a soluble form of CD59 (sCD59). This soluble recombinant version of the naturally occurring CD59 is designed and intended to protect retinal cells that are responsible for central vision by inhibiting the formation of the membrane attack complex (MAC), the terminal step of complement-mediated cell lysis. In gene therapy the cells of the retina are potentially permanently altered to make sCD59 for the life of the patient. With gene therapy only one injection is needed for the drug to be effective for the patient's entire life. This study will evaluate the safety after a single injection of AAVCAGsCD59 administered in an office setting for patients whose enrolled eye has advanced dry AMD with geographic atrophy. The initial study is 26 weeks followed by an additional 18-month safety evaluation.
The main objective of this research is to study the cognitive and cerebral mechanisms of the integration of central and peripheral visual information during normal and pathological aging (ophthalmological patients with AMD and glaucoma) through fMRI studies. To assess the effect of normal aging, research will be conducted on a group of young participants with normal vision and a group of elderly participants with normal vision. Each participant will be assessed once during an MRI (during which the brain activity and behavioral performance will be measured). In order to evaluate the effect of pathological aging, research will be conducted on AMD patients, glaucomatous patients, and age-matched controls (normal vision), evaluated only once during an MRI examination.
Macular neovascular diseases including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), pathological myopia (PM) and etc. can cause severe vision loss. It has become the focus of World Health Organization's blindness- prevention cause. A new anti—VEGF drug conbercept has been approved and showed good efficacy and safety in clinical trials. But the exact therapeutic regimen and the efficacy in the real world still needs to be further studied, the reasons are as follows: 1. The efficacy and safety data of conbercept are collected from rigorous random controlled trials (RCT) , it can not fully reflect the clinical application of conbercept in the real world . Therefore, the knowledge of the therapeutic regimen, safety and efficacy of conbercept is still limited. 2. Conbercept has been approved for wet-AMD only, but in clinical practice, some doctors applied other "off-label use" of conbercept. These "off-label use" has become a common phenomenon all over the world for the instruction book of drugs usually lag behind scientific researches. There is no specific law or regulatory document of drug off-label use in China until now. 3. Anti-VEGF drugs are expensive and often require multiple treatments, and some patients have poor or even no response to the drugs. This resulted enormous waste of medical resources. So, how to accurately find out those patients who have good response, how to develop individualized therapeutic regimen, and the response of patients in the real world need to be urgently investigated in the aspect of pharmacogenomics, and pharmacometabolomics. Therefore, the investigators plan to carry out real-world researches of conbercept on treating macular neovascular diseases has significance and urgency. The investigators intended to conduct a nationwide, non-intrusive, prospective, observational, and multicenter registration study to investigate the efficacy of conbercept in the real-world. And this study will explore the pharmacogenomics and pharmacometabolomics of conbercept, relationships of phenotype and the effectiveness of the drug, optimize the therapeutic regimen, then reduce the financial burden of patients and save the limited medical resources to achieve the purpose of accurate treatment. For three unanswered questions raised in the background, the researchers carried out the following purposes: 1. Investigate the safety and efficacy of conbercept in treating neovascular macular disease in the real world. 2. Find out whether the "off-label use" of conbercept on PCV and PM have good efficacy. 3. Explore the pharmacogenomics and pharmacometabolomics of conbercept through large-sample registration study.
Polypoidal choroidal neovasculopathy (PCV) is a subtype of wet age related macula degeneration (AMD) occuring more commonly in the Asian population. Besides the phenotypic differences, PCV is thought to have a lesser response to anti VEGF therapy which is the mainstay of treatment for other typical wet AMD. Recent trial data suggest that a combination with photodynamic therapy may help in the visual and anatomical outcome of PCV, and emerging evidence shows favourable outcomes the newer anti VEGF agent, aflibercept 2mg monotherapy. These trials however, have assessed aflibercept in a strict 2mg every 8 weekly regime. In the clinical setting, a significant an unmet need in the management of PCV is a tailored treatment regime. Here we propose a treatment regimen based on disease activity for PCV with aflibercept mono therapy. A limitation of the 2q8 regime is that it is fixed and does not vary regardless of polyp closure or anatomical outcome at the first time point of assessment (month 3). We hypothesize that after the initial 3 monthly injections of aflibercept, about 50% of PCV will close and become quiescent, and in the remaining 50%, a further 3 monthly injections will increase overall polyp closure rate. After a loadings phase of either 3 or 6 months, all eyes will start on a treat and extend regime (T&E), with a minimum period of 8 weeks and a maximum of 12 weeks between treatments with 2 week increments if PCV remains quiescent. The proposed study aims to evaluate the efficacy of a modified treat and extend regime based on disease activity with aflibercept monotherapy for PCV.
Clinical trial investigating the role of hyperspectral imaging in the management of patients undergoing standard clinical treatment for naive neovascular choroidal membranes in age-related macular degeneration.
Age-related macular degeneration (AMD) is a condition affecting 20 to 25 million people worldwide. Symptoms of AMD includes difficulty in reading, recognizing faces and completing house work which may result in increased disability which in turn increase symptoms of depression and anxiety. Depression and anxiety could also be worsened by social isolation caused by AMD. Further, AMD causes high levels of emotional distress and reduced quality of life (QoL). Automatic Self Transcending Meditation (ASTM) - a standardized category of meditation - may help reduce stress, depression, anxiety, and may enhance QoL. Automatic Self Transcending Meditation (ASTM) is a class of meditation that helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound value (mantra) to draw attention inward and permit the mind to experience a restful but alert state of consciousness. In the proposed research, the effects of ASTM on health related quality of Life (HRQoL), depression and anxiety in low-vision AMD patients will be studied. A single-center, single-blind longitudinal randomized controlled trial (RCT) will be conducted in London, ON. Patients with AMD (n = 140, 70 in each arm) will be randomized to ASTM plus treatment as usual (TAU) or TAU alone (control) arm. Data on routinely measured ophthalmic clinical variables, HRQoL, depression, and anxiety will be collected from both the arms. Statistical analysis will be conducted using STATA 15.0 to evaluate the effects of ASTM plus TAU compared to TAU alone on HRQoL, depression, and anxiety. Further, for each group - ASTM plus TAU and TAU alone - the investigators develop an association between HRQoL, depression, and anxiety with routinely measured clinical variables using mathematical models.
This is a safety follow-up study. Patients enrolled in B4711001 will be followed for a further 4 years with regular visits to assess safety.
Objective: To learn more about AMD. Eligibility: People ages 55 and older with any of the following: AMD or changes in the retina that put them at risk for AMD RPD Healthy eyes Design: Participants will be screened with: Eye exam: The pupil will be dilated with eye drops. Eye pressure and movements will be checked. Pictures will be taken of the inside of the eye. Reading an eye chart. Optical coherence tomography (OCT): The eyes are dilated. A machine measures the thickness of the retina. Participants will have a first visit that includes: Repeat of screening procedures Medical history Physical exam Questions about vision and general health Dark adapted fundus perimetry: Participants sit in the dark for 40 minutes. Then they sit at a machine that shines lights in the eyes. Dark adaption testing: Participants sit in the dark for 45 minutes. The pupils are dilated. They push a button when they see light in a machine for up to 1 hour. Participants will have annual visits for up to 5 years to repeat the tests in the first visit. Participant data may be shared for other research. ...
The objective of this study is to determine which luminance levels yield maximum differences in critical flicker fusion (CFF) scores between younger and older normal subjects.
To validate new screening instruments for eye disease, increase eye care access in underserved communities, and provide a scientifically implemented method to set up programs for eye disease screening.