NCT05932069 · VA Office of Research and Development
Active AMD Study to Improve Function in Veterans
What this study is about
Age Related Macular Degeneration (AMD) is the leading cause of vision loss among Veterans aged 50 years and older. AMD also adversely affects mortality, physical and cognitive functioning, and activities of daily living. These debilitations negatively impact quality of life for US Veterans. Unfortunately, there are no cures and few treatments.
View original scientific description
Age Related Macular Degeneration (AMD) is the leading cause of vision loss among Veterans aged 50 years and older. AMD also adversely affects mortality, physical and cognitive functioning, and activities of daily living. These debilitations negatively impact quality of life for US Veterans. Unfortunately, there are no cures and few treatments. With the increase in the aging Veteran population and the increasing prevalence of AMD, it is imperative to identify and implement strategies to limit the functional burden of AMD. To address this growing challenge, the investigators propose to test the impact of a proven exercise intervention, stationary bicycling (spinning), on visual and non-visual negative health outcomes in AMD. The work in several retinal degeneration mouse models shows that aerobic exercise significantly preserves retinal morphology and function and visual acuity. Even more exciting, the investigators' preliminary work with older Veterans with and without AMD suggests that spin cycling modestly but significantly benefits visual acuity in aged Veterans. Based on this work, the investigators propose to implement a 6-month synchronous, online group spin cycling program for Veterans with AMD, evaluating effects on physical, cognitive, and visual outcomes.
Interventions
BEHAVIORAL
SPIN
Stationary cycling
BEHAVIORAL
Non-aerobic, stretching/balance intervention Control
Balance and stretching exercise
Primary outcome measures
contrast sensitivity
Time frame: Change from Baseline contrast sensitivity at 6 months
1.Contrast Sensitivity (CS) will be determined using the CSV1000E Contrast Chart. This test provides for four rows ofsine-wave gratings. Subjects will view the chart from a distance of 2.5m. Subjects will view the chart monocularly while wearing their normal correction. CS thresholds will be assessed for both eyes individually.
Dark adaptometry
Time frame: Change from Baseline dark adaptometry at 6 months
Dark adaptometry (primary vision outcome measure). Dark adaptation or night vision is known to be affected with increasing stages of AMD. This test probes the ability of the eye to dark adapt. Participants will be asked to place their head on a chin rest in front of the machine. Each eye will be tested individually, and the opposing eye will be covered with an eye patch. While fixating on a light at the back of the machine, a bright flash will be presented to bleach the photoreceptors and then a series of dimmer flashes will appear and the participant will be asked to identify whether or not they saw the flashes by pushing a response button. The duration of the test is \~7 minutes per eye.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The investigators will recruit Veterans with a diagnosis of intermediate stage AMD in at least one eye, aged 65-89, willing and able to cooperate with assessments and interventions.
- Eligible participants will be quantified \> 26 on the Montreal Cognitive Assessment (MoCA) to meet the criteria for cognitively intact.
- Participants will be free from diseases affecting cognition or ability to engage in aerobic exercise (including but not limited to chronic heart, liver, or kidney disease) and from diseases/injuries directly affecting brain functions (including but not limited to significant closed head injury, open intracranial wounds, stroke, epilepsy, degenerative diseases of the nervous system).
- Eligible participants will be required to have stable internet access in their home.
- All subjects will speak English as a primary language and will have graduated high school so that behavioral/cognitive measures reflect effects of age, AMD, and/or aerobic exercise and not the effects of familiarity with English or lack of education.
Exclusion criteria
- Other, non-AMD, visual impairments. Potential participants with major psychiatric disorder (including but not limited to psychosis, major depression, bipolar disorder) by history will be excluded as well as individuals with current alcohol or substance use disorder.
- Additionally, individuals with cardiovascular disease and or history of myocardial infarction will not be included.
Where
- Decatur, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations