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Showing 1-10 of 86 trials for Macular Degeneration
Recruiting

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

Carmel, Indiana · Dallas, Texas

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.

Recruiting

PROTOCOL TITLE: Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration in Ophthalmology and Primary Care Settings

New York

The purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office. The photos will then be transmitted securely and analyzed by computer in the cloud (telemedicine features). Sufficient accuracy of the automatic system has been established compared to the ophthalmologist's diagnosis. In this study, we aim to validate the system against the prospectively taken OCT image and color fundus images.

Recruiting

Single Intravitreal Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Arizona · Maryland

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Recruiting

Eggs and Age-related Macular Degeneration (EggsAMD) Study.

North Carolina · Durham, NC

Age-related macular degeneration (AMD) is the primary cause of vision loss in people over the age of 55. Currently, no cure is available for individuals suffering from AMD. The purpose of this pilot study is to evaluate the feasibility of implementing a 5-month egg intervention in adults with intermediate AMD. The objective of this research study is to evaluate the feasibility of a whole egg (2 or 4 per day) intervention in older adults with intermediate AMD. The secondary objective of this research is to determine descriptive statistics, change over time and estimate effect sizes for retinal sensitivity, and vision, cognition and physical function. By completing these research objectives, the researchers hope to gain preliminary evidence in support of a larger trial that will assess the impact of egg consumption on eye health in adults with AMD.

Recruiting

A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Arizona · Phoenix, AZ

The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral intravitreal (IVT) doses.

Recruiting

Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)

North Dakota · Fargo, ND

1000 participants from up to 25 international locations who are at least 50 years old with either healthy eyes or a diagnosis of Age-Related Macular Degeneration (AMD) will be consented to provide images of their eyes for a new dataset. This dataset is an important step in developing an Artificial Intelligence (AI) based screening tool for AMD.

Recruiting

4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Arizona · Phoenix, AZ

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Recruiting

Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration

Arizona · Gilbert, AZ

This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to an active comparator. The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured at an average of Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study.

Recruiting

A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

California · Campbell, CA

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.

Recruiting

A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

Arizona · Gilbert, AZ

This study is open to adults aged 50 years and older with geographic atrophy that was diagnosed by imaging of the retina. The purpose of this study is to find out whether a medicine called BI 1584862 improves the eyes in people with geographic atrophy and to find the most suitable dose. This study has 4 treatment groups. Participants are put into groups randomly, which means by chance. Initially participants can join a BI 1584862 and a placebo group; then more participants are put randomly in 2 additional BI 1584862 groups and a placebo group. Participants are in the study for 1 year. During this time, they visit the study site 13 times. At the visits, doctors check the severity of participants' eye disease and collect information on any health problems. They take detailed pictures of the back of the eye, the retina, with imaging methods called fundus autofluorescence (FAF), near-infrared reflectance (NIR), and optical coherence tomography (OCT). They measure areas of the retina that appear healthy (bright) or start to waste away (dark, atrophy). The changes over time are then compared between the treatment groups.