Active AMD Study to Improve Function in Veterans

February 19, 2026 updated by: VA Office of Research and Development

The Active AMD Study to Improve Function in Veterans With Age Related Macular Degeneration

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aim 1 is to determine if exercise training preserves visual outcomes in Veterans with intermediate AMD when compared to a non-aerobic exercised, contact-controlled AMD group. Best corrected visual acuity, dark adaptometry, contrast sensitivity, optical coherence tomography angiography (OCT-A) and the Low Luminance Questionnaire will be assessed before, mid, and after the 6-month interventional period. In line with previous animal and human subject studies, the investigators also hypothesize a correlation between improved visual function with increases in serum brain derived neurotrophic factor (BDNF). Aim 2 is to determine if exercise improves physical and cognitive function in Veterans with AMD when compared to non-aerobic exercised, contact-controlled AMD group. The investigators will test the timed-up-and-go (TUG) and a neuropsychological battery, mid- and post 6-month interventional period. These provide a robust index of other health, well-being, and quality of life related outcomes in numerous older adult patient populations. In line with the preliminary studies, the investigators' working hypothesis is that 6 months of exercise will result in a clinically significant improvement in TUG performance as well as improved cognitive-executive functions. The investigators expect that the results from achieving these aims will set the stage for a larger, multi-site trial powered to test the hypothesis that virtual exercise can slow the progression of AMD while improving physical and cognitive function and quality of life in Veterans. Thus, the investigators propose an accessible, low-cost intervention that can be easily scalable to other VA centers to improve engagement/adherence, while also improving visual and functional capacity for Veterans with AMD who are at high risk for comorbidities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033-4004
        • Recruiting
        • Atlanta VA Medical and Rehab Center, Decatur, GA
        • Principal Investigator:
          • Joe R. Nocera, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SPIN
Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session
Behavioral: SPIN
Stationary cycling
Active Comparator: Non-aerobic, stretching/balance intervention Control
For this arm of the intervention, randomized participants followed the same guidelines as the SPIN group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the SPIN group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises
Behavioral: Non-aerobic, stretching/balance intervention Control
Balance and stretching exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline contrast sensitivity at 6 months
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.
Change from Baseline dark adaptometry at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity
Time Frame: Change from best corrected visual acuity at 6 months
Best Corrected Visual Acuity (BCVA) is measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart Subjects will be placed at a distance of 4 m, if at least the top line can be read correctly, and encouraged to give a response for each letter until 5 successive incorrect answers are recorded. This test will take 10 minutes to complete.
Change from best corrected visual acuity at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joe R. Nocera, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C4563-R
  • 1I01RX004563 (U.S. NIH Grant/Contract: VA RR&D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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