Clinical Research Directory

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease which causes people to lose their vision over time. AMD damages the macula, which is in the middle of the retina - the light sensitive part at the back of the eye. In AMD, the cells in the macula die over time, usually over several years, leading to vision loss. When AMD gets worse, it can turn into either geographic atrophy (GA), neovascular AMD, or both. This study is for people in Japan of 40 years of age or older, who have geographic atrophy. The main aim of this study is to collect information about the safety of ASP3021 and how well people tolerate treatment with ASP3021. During the study, people will receive monthly injections of ASP3021 for 12 months. ASP3021 is given by injection into the affected eye. This procedure is called an intravitreal injection. People will be in the study for about 1 year. People will visit their study clinic several times for health checks.

NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration

This study will evaluate the safety, tolerability, and preliminary efficacy of NG101 AAV gene therapy administered by subretinal injections into a single selected eye as a single selected dose for patients with wet age-related macular degeneration (wAMD).

National Eye Institute Biorepository for Retinal Diseases

Background: \- To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time. They also want to study body tissues and blood to understand the nature of eye disease. Studying genes, cells, and tissues may help them understand why some people get eye problems and others do not, or why some people respond to treatment while others do not. Researchers want to collect physical samples and personal data to develop a National Eye Institute database. Objectives: \- To collect health information and blood and tissue samples from people with and without eye diseases, to be used in research studies. Eligibility: * Individuals at least 2 years of age with different types of eye disease. * Healthy volunteers with no history of eye disease. Design: * Participants may be recruited from National Eye Institute studies or may be referred from other sources. * Participants will be screened with a physical exam and medical history. They will also have a full eye exam. Questions will be asked about family medical history, especially about eye disease. * Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and urine, may be collected as needed. Adult participants may also provide a skin sample. * Tissue or fluid from eye collected as part of eye care or treatment may also be added to the database. * No treatment will be provided as part of this study.

Dark Adaptation in Participants With Age-Related Macular Degeneration

Background: Macular degeneration can cause permanent loss of central vision. This vision is important for seeing details. Age-related macular degeneration (AMD) is the leading cause of vision loss in people over 55 in the United States. Researchers want to follow people with AMD to study the early to middle stages of the disease. Objective: To follow for another 5 years participants who completed NIH study 11-EI-0147. Eligibility: Participant was enrolled in and completed study 11-EI-0147. Design: Participants will have at least 6 study visits over 5 years. Each visit takes about 5 hours. At visit 1, participants will be asked about their medical and eye disease history. They will have an eye exam. The exam will test vision, eye pressure, and eye movements. The pupil will be dilated with eye drops. Participants will have baseline exams. These include a health history and questions about problems that affect their eyes under different lighting. They will answer these questions each year. At each visit, participants will have some or all of these tests: Eye exam Dark adaptation protocol. This measures how fast the eyes recover when exposed to decreasing levels of light. The pupil will be dilated with eye drops. Participants will sit in front of a metal box with a camera inside. They will push a button when they see a light in the machine. View a bright background light for 5 minutes. After the light is turned off participants will push a button when a blue or red light is seen. Sit in the dark for about 30 minutes. Participants will push a button when they see a blue or red light.

AMD Ryan Initiative Study (ARIS)

Objective: To learn more about AMD. Eligibility: People ages 55 and older with any of the following: Early 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....

A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease which causes people to lose their sharp central vision over time. Aging damages the macula, which is in the middle of the retina - the light-sensitive part at the back of the eye. There are 2 types of AMD - wet AMD and dry AMD. The advanced stage of dry AMD causes vision loss. This is known as geographic atrophy. AMD makes everyday tasks like reading or driving difficult. ASP7317 is a potential new treatment for people with AMD. ASP7317 are human stem cells which have changed into cells found in the retina. ASP7317 is injected under the macula. It is hoped that ASP7317 will replace some of the damaged cells in the macula and improve vision for people with dry AMD. Before ASP7317 is available as a treatment, the researchers need to check its safety and how well it is tolerated. They will also check for signs of improved vision. People taking part in this study will be older people who have geographic atrophy caused by dry AMD. This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP7317. There will be 3 doses of ASP7317. These are low, medium and high numbers of cells. ASP7317 will be injected under the macula after the person is given either a local or a general anesthetic. To prevent the body from rejecting the cells, people will take tablets of tacrolimus a few days before receiving ASP7317 for up to a few weeks afterwards. Other medicines will be taken during this time to stop infections. There will be 2 groups in the study. Group 1 will be people with severe vision loss and Group 2 will be people with moderate vision loss. There will be different small groups of people within Group 1 and Group 2, with each small group receiving 1 of the 3 doses of ASP7317. Different small groups of people within Group 1 and Group 2 will receive lower to higher doses of ASP7317. Each small group will only receive 1 dose. Group 1 will start treatment first. At each dose, a medical expert panel will check the results of the first person in the group to decide if the rest of the group will receive the same dose. Then, the panel will decide if more people may receive the same dose or if the next group may receive the next highest dose. The panel will use the results from the lower dose of Group 1 to decide when Group 2 starts treatment (also at the lower dose). The panel will also use the results of the middle and higher doses in Group 1 to decide when and how many people in Group 2 can receive these doses. During the study, people will visit the clinic several times for up to 12 months (1 year). During all visits, the study doctors will check for any medical problems after receiving ASP7317. Vital signs will be checked a few days before treatment with ASP7317 and up to about a month afterwards. Vital signs include blood pressure, pulse, and temperature. At some visits, the study doctors will also take blood samples for blood tests. At most visits, people will have eye tests and have different images, scans, and measurements taken. This could be for the affected eye or both eyes, depending on the test. People can visit the clinic extra times, if needed.

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice

In this cohort study, the investigators will test vision screenings in Danish general practice for patients over 70 years of age with minimum one chronic condition. The main outcome is detection of vision impairment and secondary outcome is detection of conditions needing ophthalmologic follow-up but not presenting vision impairment at present time.

Natural History of Geographic Atrophy Associated With Age-Related Macular Degeneration

Background: Age-related macular degeneration (AMD) affects the macula in the eye. This is the central part of the retina. It is needed for sharp, clear vision and activities like reading and driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. An advanced form of AMD is called geographic atrophy or GA. It happens when light-sensitive cells in the macula die so much that central vision decreases. Objective: To learn more about geographic atrophy associated with age-related macular degeneration. Eligibility: Adults at least 55 years old with a certain kind of GA. They must be enrolled in study 08-EI-0102, 08-EI-0169, 08-EI-0043, 12-EI-0042, or 11-EI-0147 but no other studies. Design: Participants will be screened with medical history, physical exam, and an eye exam. Participants will have study visits every 3 months for 15 months, then every 6 months. They will be in the study almost 4 years. Visits will last about 8 hours. At each visit, participants may have: * Medical and eye history. Participants will answer questions about their general health and eye health. They may answer written questions about how their eye problems affect their life. * Eye exam and photographs. Eye pressure will be measured and eye movements will be checked. Pupils will be dilated with drops. The thickness of the retina will be measured and photos of the eye may be taken.

Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD. Participants will: * Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months. * Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.

Age-Related Eye Disease Study (AREDS) Follow-Up

This study is a 5-year extension of the AREDS protocol, in which investigators followed the natural course of age-related macular degeneration (AMD) and cataracts. Participants in the former AREDS protocol are eligible for this study. Participants have a complete eye examination once a year and are contacted at least once a year between visits to check on their status. The eye examination includes measurement of visual acuity (vision chart test) and examination of the inside of the eye after the pupils have been dilated with eye drops. Photographs of the inside of the eye may be taken using a special camera that flashes a bright light in the eye. A blood sample may be obtained to test for cholesterol level and genes related to inflammation.

Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

The Phase 1 safety study of VOY-101 is comprised of escalating dose Cohorts, followed by a Phase 2 at the recommended phase 2 dose.

AMD and Validation Rod-Meditated Dark Adaptation With Everyday Task Performance

The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

Study of Dark Adaptation in Age-Related Macular Degeneration

Background: * Age-related macular degeneration (AMD) is a leading cause of vision loss in individuals over 55 years of age. It can cause permanent loss of central vision, which is important for seeing fine details and long distances. AMD has two forms: wet AMD and dry AMD. Most people with AMD have dry AMD. But dry AMD can progress to wet AMD. Wet AMD is the more serious form and can result in severe vision loss. * A method to identify and monitor the early to middle stages of AMD may help researchers develop new treatments to stop the disease before it becomes severe. In early dry AMD, people cannot see well at night. Researchers want to study whether a procedure that measures how the eye adjusts to the dark can help to identify and monitor early to middle dry AMD. Objectives: \- To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor early to middle dry age-related macular degeneration. Eligibility: \- People at least 50 years of age who have no AMD. Others who have early to middle dry AMD in at least one eye. Design: * People will be screened with a physical examination, medical history, blood and urine tests, and a full eye exam. * This study will last 5 years and require at least 9 visits to NIH. (First visit; study visits at months 3, 6, 12, 18, and 24; and 3 yearly followup visits). * Up to 10 people will be asked to come back to the clinic 1 week after their first visit. They will be asked to test the device to be used in the study. * Participants will have baseline exams. These questions will be about problems that affect their eyes under different lighting conditions. * At every visit, participants will answer questions about general health and current medications (including any vitamins or supplements). They will also have a full eye exam and a 20- to 40-minute test. This test measures how fast the eyes recover in response to decreasing levels of light. The test also measures how sensitive the eyes are to these conditions. * Participants will continue to have these tests at the yearly followup examinations. They will be treated with the standard of care for any eye conditions they have or may develop during the study.

Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is: * to evaluate patterns of increased autofluorescence FPF in the setting of geographic atrophy Participants will undergo FPF imaging using the OcuMet Beacon system.

Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration

The main objective of the study is evaluation of the safety and tolerability of OpRegen - Human embryonic stem cell-derived retinal pigment epithelial (RPE) cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.

A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.

Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy

This interventional study is a single-center, open label, 26-week study, designed to evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). Up to 5 subjects will receive study medication. Study treatment will be administered by intravitreal injections. Number of participants has been expanded to 30. Participants will have 7 scheduled visits - Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26. Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response.

Effects of Goji vs. Fiber on Macular Degeneration

The goal of this project is to conduct a clinical trial in 60 participants ranging from age 65-95 who are at risk for age-related macular degeneration (AMD). The study will evaluate the effects of 14g of goji berry intake or an equivalent amount and type of fiber, five days a week for six months, on visual health, gut microbiome profiles, skin carotenoid measures, and lipoprotein profiles.

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. Geographic Atrophy (GA) is an advanced form of dry AMD. The purpose of this study is to assess the adverse events and how intravitreal ABBV-6628 moves through the body of adult participants with secondary to age-related macular degeneration ABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age-related macular degeneration. Participants in the Stage 1 part will be placed in 1 of 4 groups, called treatment arms. Participants in Stage 2 will be placed into 1 of 2 groups. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis GA secondary to age-related macular degeneration will be enrolled. Around 66 participants will be enrolled in the study at approximately 27 sites across the US. Participants in Stage 1 will be given ABBV-6628 as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection) with dose escalation. Participants in Stage 2 will receive ABBV-6628 or SYFOVRE, an approved treatment for geographic atrophy, administered as per the FDA-approved label. The treatment duration is approximately 22 months and 3 months of follow-up. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Stem Cell Ophthalmology Treatment Study II

This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.

An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

This is a multicenter prospective study in participants with intermediate age-related macular degeneration (iAMD). One primary objective of this study is to assess iAMD disease progression, by the timeline and rates of conversion for high-risk iAMD at baseline to more advanced atrophic AMD stages. The other primary objective of this observational study is to assess the feasibility of measuring the rate of photoreceptor loss as a potential clinical endpoint. The study will consist of an observation period of approximately 3 years (\~144 weeks) for participants.

A Study of the SING IMT in an Israeli Cohort

The objective of this single center study is to determine the safety of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in a small sample of patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD) in an Israeli Cohort