Age Related Macular Degeneration (AMD)NCT05932069
Active AMD Study to Improve Function in Veterans
A study testing SPIN in people with Age Related Macular Degeneration (AMD), run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 89 years
- Conditions the study is for
- Age Related Macular Degeneration (AMD)
- What is being tested?
- SPIN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
Joe R Nocera, PhD, 404-321-6111 ext. 6354, joenocera@emory.edu
Joe R. Nocera, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Age Related Macular Degeneration (AMD)
- Being tested
- SPIN, Non-aerobic, stretching/balance intervention Control
- Keywords
- Age Related Macular Degeneration (AMD)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPINBehavioural
Stationary cycling
Non-aerobic, stretching/balance intervention ControlBehavioural
Balance and stretching exercise
| Study group | Role | What they receive |
|---|---|---|
| SPIN | Experimental | Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session Receives: Behavioral: SPIN |
| Non-aerobic, stretching/balance intervention Control | Active comparator | 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 Receives: Behavioral: Non-aerobic, stretching/balance intervention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
contrast sensitivity
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.
Measured: Change from Baseline contrast sensitivity at 6 months
Dark adaptometry
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.
Measured: Change from Baseline dark adaptometry at 6 months
Secondary outcomes (1)
Best Corrected Visual Acuity
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.
Measured: Change from best corrected visual acuity at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Mar 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joe R. Nocera, PhD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932069
- Sponsor's protocol ID
- C4563-R
- Other IDs
- 1I01RX004563
- Status last verified
- Feb 2026
- First submitted
- 25 May 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bello MO, Mammino KM, Vernon MA, Wakeman DG, Denmon CA, Krishnamurthy LC, Krishnamurthy V, McGregor KM, Novak TS, Nocera JR. Graded Intensity Aerobic Exercise to Improve Cerebrovascular Function and Performance in Older Veterans: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 26;13:e58316. doi: 10.2196/58316.
PubMed 39326042
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Active AMD Study to Improve Function in Veterans With Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05932069
- Acronym / sponsor ID
- C4563-R
- Conditions
- Age Related Macular Degeneration (AMD)
- Keywords
- Age Related Macular Degeneration (AMD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPIN | Experimental | Behavioral: SPINExercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session |
| Non-aerobic, stretching/balance intervention Control | Active comparator | Behavioral: Non-aerobic, stretching/balance intervention ControlFor 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 |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPINStationary cycling | Behavioural | SPIN |
| Non-aerobic, stretching/balance intervention ControlBalance and stretching exercise | Behavioural | Non-aerobic, stretching/balance intervention Control |
Primary outcome
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.
1 secondary outcome
Best Corrected Visual Acuity
Time frame: Change from best corrected visual acuity at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Derived from this study: PubMed 39326042Bello MO, Mammino KM, Vernon MA, Wakeman DG, Denmon CA, Krishnamurthy LC, Krishnamurthy V, McGregor KM, Novak TS, Nocera JR. Graded Intensity Aerobic Exercise to Improve Cerebrovascular Function and Performance in Older Veterans: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 26;13:e58316. doi: 10.2196/58316.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joe R. Nocera, PhD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIN in people with Age Related Macular Degeneration (AMD), run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joe R Nocera, PhD ((404) 321-6111 ext. 6354, joenocera@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contrast sensitivity (time frame: Change from Baseline contrast sensitivity at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05932069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.