Age Related Macular DegenerationNCT03275753
Visual Function Tests in Age-related Macular Degeneration
An observational study of Age Related Macular Degeneration, run by ORA, Inc. at 1 site in United States.
Trial summary
The goal of this study is to assess a battery of visual function tests in subjects with non-exudative age-related macular degeneration Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Visual Function Tests
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 31 Dec 2022
- 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 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: Normal Population (N=50) VA of 20/25 or better in the study eye with no prior diagnosis of any retinal or ocular diseases. Group 2: Early Dry AMD Population (N=50) VA of 20/40 or better in the study eye with clinical diagnosis of early dry AMD based on fundus features. Group 3: Intermediate Dry AMD Population (N=50) VA of 20/40 or better in the study eye with clinical diagnosis of intermediate dry AMD based on fundus features. Group 4: Advanced Dry AMD Population (N=50) Clinical diagnosis of advanced dry AMD based on fundus features in the study eye
Who may be able to join
- All Subjects Must:
- Be 60 years of age or older;
- Provide written informed consent;
- Be willing and able to follow all instructions and attend the study visits;
- Must be able to perform all study procedures;
- Normal Subjects:
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- Have BCVA of 20/25 or better in the study eye;
- Have no history or clinical evidence of AMD, retinal diseases or any other ocular pathologies in either eye;
- AMD Subjects:
- Have BCVA of 20/40 or better in the study eye;
- Have a clinical diagnosis of non-exudative AMD in the study eye;
Who cannot join
- All subjects must not have any of the below criteria
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- Have a diagnosis of wet AMD in the study eye;
- Have any other hereditary or acquired retinal diseases in either eye ;
- Have glaucoma or other optic nerve diseases in either eye;
- Have corneal or other anterior segment diseases in either eye;
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- Have significant cataract in the study eye;
- Have a history of ocular trauma or ocular surgery (other than cataract removal) in the study eye;
- Have a history of uncontrolled systemic disease (e.g. poorly controlled hypertension or poorly controlled diabetes);
- Have a history of seizures;
- On psychotropic medications;
- Any other symptoms or conditions that could, in the opinion of the investigator, interfere with study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: Visual Function Tests in Non-Exudative Age-Related Macular Degeneration and Normal Subjects
The goal of this study is to assess a battery of visual function tests in subjects with non-exudative age-related macular degeneration
Read the detailed description
Age-related macular degeneration (AMD) is one of the leading causes of visual impairment among elderly populations in developed countries. Majority of AMD patients (80%) suffer from the dry or non-exudative form of the disease. Currently there are no approved treatments for dry AMD. Clinical development of therapeutic agents for dry AMD is limited by slow progressing nature of the disease as well as the lack of sensitive endpoints to assess therapeutic efficacy. Visual acuity, the commonly used functional endpoint, remains minimally affected during early stages of dry AMD. Thus novel visual function endpoints, that can identify functional deficits during early stages of dry AMD prior to development of geographic atrophy, are needed. In the current study a battery of visual function tests will be evaluated in subjects with different stages of dry AMD and normal controls, to assess their sensitivity and feasibility as potential functional endpoints for dry AMD.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Visual Function Tests
- Keywords
- Visual function, Critical flicker fusion, Dark adaptation, Reading test
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Function TestsOther
All subjects will undergo a battery of visual function tests
| Study group | Role | What they receive |
|---|---|---|
| Normal Population | VA of 20/25 or better in the study eye with no prior diagnosis of any retinal or ocular diseases Receives: Other: Visual Function Tests | |
| Early Dry AMD Population | VA of 20/40 or better in the study eye with clinical diagnosis of early dry AMD Receives: Other: Visual Function Tests | |
| Intermediate Dry AMD Population | VA of 20/40 or better in the study eye with clinical diagnosis of intermediate dry AMD Receives: Other: Visual Function Tests | |
| Advanced Dry AMD Population | Clinical diagnosis of advanced dry AMD in the study eye Receives: Other: Visual Function Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical flicker fusion
Critical flicker fusion will be tested using a computer based test for different stimulus colors, white, red, green and blue. A wide range of luminance and contrast levels will be tested. The subject would be seated in front of the monitor. The non-study eye will be occluded. Subjects would be given adequate practice tests prior to performing the actual test. The stimulus will be presented on the monitor screen and the subject indicates perceiving the stimulus by pressing a test button.
Measured: At study visit through study completion, an average of 2 years
Secondary outcomes (4)
Dark adaptation
Dark adaptation function will be assessed with dilated pupils using computer based stimuli following photo bleach. Subject will be seated in front of the test monitor with best correction in place for the study eye. The subject will be instructed to keep fixating on a red fixation cross in the center of the monitor and respond to perceiving the stimulus presented by pressing the response trigger button. All stimuli will be presented in random order for all intensities presented. The stimulus intensity is programmed to decrease in intensity with time. The test will be terminated after 20 minutes of recording. Dark adaptation curve will be generated and rod-cone recovery time (in minutes) will be derived from the curve.
Measured: At study visit through study completion, an average of 2 years
Reading Tests
Reading tests will be performed using an electronic tablet device. The subject will be seated in a comfortable position with the non-tested eye occluded. The tablet will be set up in a table right in front of the subject at a viewing distance of 40cm. The subject will be given detailed instructions on the test procedures and outcomes. The goal of this test to assess reading speed of the study eye under a variety of conditions such as high contrast-high luminance, low contrast, low luminance, crowded letters, pepper words of different lengths and vanishing optotypes. Each challenge will be tested using a different passage of similar difficulty level. For each passage, reading speed will be estimated as the time taken to accurately read the entire passage and recorded in words per minute (WPM).
Measured: At study visit through study completion, an average of 2 years
Color vision function
Color vision function will be assessed to test L, M and S cone functions. During the test, a letter will briefly flash on the screen. The subject then must verbally identify the letter and/or its orientation. The response of the subject is then recorded by the technician. If correct, the next letter is presented at decreased color contrast relative to the background. The test continues in this manner until the subject incorrectly identifies the presented letter. At that point, the stimulus is presented at the next higher contrast level. This continues until the subject correctly identifies the presented letter. The test then terminates.
Measured: At study visit through study completion, an average of 2 years
Shape discrimination
Shape discrimination will be tested by presenting a two-alternative forced choice stimulus to the subject on a computer device (monitor or tablet). The subject will be asked to identify the stimulus which is modulated and which is not. The test shall be performed at full room lighting for photopic sensitivity as well as in reduced lighting (mesopic) conditions. The effect of eccentricity may be tested by presenting successively larger targets with foveal fixation.
Measured: At study visit through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start21 Sep 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Why it stopped: Study terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Chin, OD, Principal investigator, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275753
- Sponsor's protocol ID
- 17-270-0001
- Status last verified
- Apr 2024
- First submitted
- 8 Aug 2017
- Last updated
- 25 Apr 2024
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function Tests in Non-Exudative Age-Related Macular Degeneration and Normal Subjects
- ClinicalTrials.gov ID
- NCT03275753
- Acronym / sponsor ID
- 17-270-0001
- Conditions
- Age Related Macular Degeneration
- Keywords
- Visual function, Critical flicker fusion, Dark adaptation, Reading test
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated by Sponsor
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Sep 2017 (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.
The goal of this study is to assess a battery of visual function tests in subjects with non-exudative age-related macular degeneration
Detailed description
Age-related macular degeneration (AMD) is one of the leading causes of visual impairment among elderly populations in developed countries. Majority of AMD patients (80%) suffer from the dry or non-exudative form of the disease. Currently there are no approved treatments for dry AMD. Clinical development of therapeutic agents for dry AMD is limited by slow progressing nature of the disease as well as the lack of sensitive endpoints to assess therapeutic efficacy. Visual acuity, the commonly used functional endpoint, remains minimally affected during early stages of dry AMD. Thus novel visual function endpoints, that can identify functional deficits during early stages of dry AMD prior to development of geographic atrophy, are needed. In the current study a battery of visual function tests will be evaluated in subjects with different stages of dry AMD and normal controls, to assess their sensitivity and feasibility as potential functional endpoints for dry AMD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Population | – | Other: Visual Function TestsVA of 20/25 or better in the study eye with no prior diagnosis of any retinal or ocular diseases |
| Early Dry AMD Population | – | Other: Visual Function TestsVA of 20/40 or better in the study eye with clinical diagnosis of early dry AMD |
| Intermediate Dry AMD Population | – | Other: Visual Function TestsVA of 20/40 or better in the study eye with clinical diagnosis of intermediate dry AMD |
| Advanced Dry AMD Population | – | Other: Visual Function TestsClinical diagnosis of advanced dry AMD in the study eye |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Normal Population (N=50) VA of 20/25 or better in the study eye with no prior diagnosis of any retinal or ocular diseases. Group 2: Early Dry AMD Population (N=50) VA of 20/40 or better in the study eye with clinical diagnosis of early dry AMD based on fundus features. Group 3: Intermediate Dry AMD Population (N=50) VA of 20/40 or better in the study eye with clinical diagnosis of intermediate dry AMD based on fundus features. Group 4: Advanced Dry AMD Population (N=50) Clinical diagnosis of advanced dry AMD based on fundus features in the study eye
Key inclusion criteria (11 listed)
- All Subjects Must:
Key exclusion criteria (12 listed)
- All subjects must not have any of the below criteria
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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 |
|---|---|---|
| Visual Function TestsAll subjects will undergo a battery of visual function tests | Other | Advanced Dry AMD Population, Early Dry AMD Population, Intermediate Dry AMD Population, Normal Population |
Primary outcome
Critical flicker fusion
Time frame: At study visit through study completion, an average of 2 years
Critical flicker fusion will be tested using a computer based test for different stimulus colors, white, red, green and blue. A wide range of luminance and contrast levels will be tested. The subject would be seated in front of the monitor. The non-study eye will be occluded. Subjects would be given adequate practice tests prior to performing the actual test. The stimulus will be presented on the monitor screen and the subject indicates perceiving the stimulus by pressing a test button.
4 secondary outcomes
Dark adaptation
Time frame: At study visit through study completion, an average of 2 years
Reading Tests
Time frame: At study visit through study completion, an average of 2 years
Color vision function
Time frame: At study visit through study completion, an average of 2 years
Shape discrimination
Time frame: At study visit through study completion, an average of 2 years
Results and safety
The study was stopped early (reason given: Study terminated by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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.
Jason Chin, OD principal investigator
ORA, Inc.
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, run by ORA, Inc. 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 11 inclusion and 12 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: stopped early, as of the sponsor's last update on 25 Apr 2024. 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 stopped early (reason given: Study terminated by Sponsor). Results are not available in the source record.
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?
Critical flicker fusion (time frame: At study visit through study completion, an average of 2 years). 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 25 Apr 2024.