Age-related Macular Degeneration (AMD)AMDNCT05780931
Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration
An observational study of Age-related Macular Degeneration (AMD), run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study will help develop new methods of rehabilitating Veterans with vision loss due to Age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration (AMD)
- What is being tested?
- Study-specific rehabilitation (SSR) procedures
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 29 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans with vision loss caused by age-related macular degeneration
Who may be able to join
- The subject is a Veteran
- The subject has best-corrected visual acuity (BCVA) of 20/40 or worse in each eye, as determined by the standard Charlie Norwood VA Medical Center (CNVAMC) optometric tests
- The subject has visual field deficit of 10O in either eye as determined by the Octopus 900 perimetry (Haag-Streit Diagnostics, Haag-Streit USA, Mason, OH) administered by CNVAMC. (When the deficit/s are binocular, they do not necessarily have to be in binocularly corresponding positions)
- The subject has received a formal clinical diagnosis of age-related macular degeneration (AMD) in one or both eyes (binocular AMD does not necessarily have to be in binocularly corresponding positions)
- The subject has visual deficit in either eye (wavy lines and/or missing/darkened areas on the grid) determined by the standard Amsler Grid Test
- The subject has not yet started any rehabilitative treatment for AMD-related vision loss
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- Both eyes of the subject are otherwise age-appropriately stable, and neither eye has any other visual defects, as determined by the standard CNVAMC ophthalmological examination
- The subject must be able to understand the nature and individual consequences of the study
- The subject must be able to provide signed and dated informed consent before start of any participation in the study procedures (11)Women with childbearing potential must test negative for pregnancy using a standard urine test prior to participating in each functional magnetic resonance imaging (fMRI) procedure. (This exclusion criterion is mandated by the Augusta University Institutional Review Board [AU IRB], which also serves as the IRB of record of the CNVAMC. It is intended as an extra precautionary measure to help ensure the health and safety of this vulnerable population. The proposed study will comply with this requirement.)
Who cannot join
- According to the patient's VA clinical records, the patient has one or more clinically diagnosed neurological disorder
- According to the patient's VA clinical records, the patient has one or more clinically diagnosed cognitive deficits
- According to the patient's VA clinical records, the patient has been clinically diagnosed with a psychiatric disorder that would make it unduly uncomfortable or otherwise clinically inadvisable for the subject to participate in the study
- According to the patient's VA clinical records, according to the patient, or both, the patient has motor disorder/s that would make it unduly uncomfortable or otherwise clinically inadvisable for the subject to participate in the study
- According to the patient's VA clinical records, according to the patient, or both, the patient has an MR-incompatible implant and/or another condition (e.g., claustrophobia) that would make it inadvisable for the subject to participate in MR imaging or any other study procedure
- The patient does not understand the informed consent information and/or the standard study instructions in spoken or written English, and/or is unable to follow study instructions. [The purpose of this exclusion criterion, required by the AU IRB, is to help ensure that the subjects adequately understand all the information relevant to providing informed consent, as well as the study instructions.]
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- Inability to give informed consent to participate in the study
- Pregnancy, as determined by a standard urine test for pregnancy
- Participation in other study/studies including an investigational drug or device during the present study
Trial locations and contacts
1 site in 1 country.
United States1 site
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, 30904-6258
About this study
Official title: Development of New Approaches to Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration
This study will help develop new methods of rehabilitating Veterans with vision loss due to Age-related macular degeneration.
Read the detailed description
The purpose of this research study is to develop new and improved methods of helping vision-impaired Veterans see better by using hands as "seeing eyes". This study will focus on Veterans with a common form of eye disease called age-related macular degeneration that affects older individuals.
- Conditions
- Age-related Macular Degeneration (AMD)
- Being tested
- Study-specific rehabilitation (SSR) procedures
- Keywords
- Maculopathy, Macular dystrophy, Drusen, wet AMD, dry 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.
Study-specific rehabilitation (SSR) proceduresBehavioural
Also called Study-related rehabilitation procedures
Study-specific rehabilitation procedures will systematically manipulated the spatial or temporal synchrony (or coordination) of visual vs. haptic inputs that the subjects receive.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | This is the group of study subjects which will undergo study-related rehabilitation procedures. Receives: Behavioral: Study-specific rehabilitation (SSR) procedures | |
| Control Group | This is the group of study subjects which will undergo control (sham) rehabilitation procedures (in addition to all their regularly scheduled treatments and interventions). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of object recognition
This outcome will be measured as the accuracy (% correct) with which the study subjects recognize the text objects before, during and after their participation in the study procedures.
Measured: 6-10 weeks
Response of brain regions of interest (ROI) as reflected in the BOLD (blood oxygenation level-dependent) response
This outcome will be measured as changes (if any) of the BOLD responses of brain ROIs before, during and after their participation in the study procedures.
Measured: 6-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Jan 2024
- Primary completion29 Sep 2026
- Study completion29 Sep 2026
Why it stopped: I was instructed to stop the study, because the underlying VA grant has run out of funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Augusta University
- Responsible party
- Sponsor
- Investigators
- Jay Hegde, PhD, Principal investigator, Charlie Norwood VA Medical Center, Augusta, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780931
- Sponsor's protocol ID
- C4099-P
- Other IDs
- I21RX004099-01A1
- Acronym
- AMD
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of New Approaches to Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05780931
- Acronym / sponsor ID
- AMD / C4099-P
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- Maculopathy, Macular dystrophy, Drusen, wet AMD, dry AMD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: I was instructed to stop the study, because the underlying VA grant has run out of funds.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Augusta University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 29 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 23 Mar 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.
This study will help develop new methods of rehabilitating Veterans with vision loss due to Age-related macular degeneration.
Detailed description
The purpose of this research study is to develop new and improved methods of helping vision-impaired Veterans see better by using hands as "seeing eyes". This study will focus on Veterans with a common form of eye disease called age-related macular degeneration that affects older individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Behavioral: Study-specific rehabilitation (SSR) proceduresThis is the group of study subjects which will undergo study-related rehabilitation procedures. |
| Control Group | – | –This is the group of study subjects which will undergo control (sham) rehabilitation procedures (in addition to all their regularly scheduled treatments and interventions). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with vision loss caused by age-related macular degeneration
Key inclusion criteria (9 listed)
- The subject is a Veteran
- The subject has best-corrected visual acuity (BCVA) of 20/40 or worse in each eye, as determined by the standard Charlie Norwood VA Medical Center (CNVAMC) optometric tests
- The subject has visual field deficit of 10O in either eye as determined by the Octopus 900 perimetry (Haag-Streit Diagnostics, Haag-Streit USA, Mason, OH) administered by CNVAMC. (When the deficit/s are binocular, they do not necessarily have to be in binocularly corresponding positions)
- The subject has received a formal clinical diagnosis of age-related macular degeneration (AMD) in one or both eyes (binocular AMD does not necessarily have to be in binocularly corresponding positions)
- The subject has visual deficit in either eye (wavy lines and/or missing/darkened areas on the grid) determined by the standard Amsler Grid Test
Key exclusion criteria (9 listed)
- According to the patient's VA clinical records, the patient has one or more clinically diagnosed neurological disorder
- According to the patient's VA clinical records, the patient has one or more clinically diagnosed cognitive deficits
- According to the patient's VA clinical records, the patient has been clinically diagnosed with a psychiatric disorder that would make it unduly uncomfortable or otherwise clinically inadvisable for the subject to participate in the study
- According to the patient's VA clinical records, according to the patient, or both, the patient has motor disorder/s that would make it unduly uncomfortable or otherwise clinically inadvisable for the subject to participate in the study
- According to the patient's VA clinical records, according to the patient, or both, the patient has an MR-incompatible implant and/or another condition (e.g., claustrophobia) that would make it inadvisable for the subject to participate in MR imaging or any other study procedure
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 |
|---|---|---|
| Study-specific rehabilitation (SSR) proceduresAlso: Study-related rehabilitation proceduresStudy-specific rehabilitation procedures will systematically manipulated the spatial or temporal synchrony (or coordination) of visual vs. haptic inputs that the subjects receive. | Behavioural | Treatment Group |
Primary outcome
Accuracy of object recognition
Time frame: 6-10 weeks
This outcome will be measured as the accuracy (% correct) with which the study subjects recognize the text objects before, during and after their participation in the study procedures.
Response of brain regions of interest (ROI) as reflected in the BOLD (blood oxygenation level-dependent) response
Time frame: 6-10 weeks
This outcome will be measured as changes (if any) of the BOLD responses of brain ROIs before, during and after their participation in the study procedures.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- 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. This study is not recruiting at the moment.
Jay Hegde, PhD principal investigator
Charlie Norwood VA Medical Center, Augusta, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 5 Oct 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of object recognition (time frame: 6-10 weeks). 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?
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 5 Oct 2026.