Age-related Macular DegenerationNCT04087356
Age-related Macular Degeneration (AMD) and Cardiovascular Disease
An observational study of Age-related Macular Degeneration and Coronary Artery Disease, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the link between age-related macular degeneration (AMD or ARMD) and coronary artery disease (CAD). Age-related macular degeneration is a medical condition which may result in blurred or no vision in the center of vision. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Coronary Artery Disease, Cardiovascular Diseases
- What is being tested?
- Blood draw
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2019to 20 Dec 2020
- How long will I take part?
- 1 Year
- 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: Patients with AMD with and without RMD
Who may be able to join
- Clinical diagnosis of age-related macular degeneration in at least one eye.
- Patients can have unilateral, but not bilateral CNV. In the case of unilateral CNV, the eye without the CNV will be the study eye.
- Age greater than 50
- Willing and able to comply with clinic visit and study-related procedures
- Provide signed informed consent
- Able to understand and complete study-related questionnaire
- Be able to tolerate dilating drops
Who cannot join
- Bilateral CNV
- Other retinal degenerations and retinal vascular diseases such as diabetic retinopathy or macular edema, prior retinal surgery
- Pregnant, lactating, or currently expecting a child
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Eye and Ear Infirmary
New York, New York, 10003
Theodore Smith, MD, 212-979-4579, rolandtheodore.smith@mssm.edu
Theodore Smith, MD
About this study
The purpose of this research study is to investigate the link between age-related macular degeneration (AMD or ARMD) and coronary artery disease (CAD). Age-related macular degeneration is a medical condition which may result in blurred or no vision in the center of vision. Coronary artery disease is a blockage of one or more arteries that supply blood to the heart. The study will specifically look at the macular changes that occur in the retina, which is the sensory membrane that lines the inner surface at the back of the eyeball, and the relationship between coronary heart disease and the risk factors.
Read the detailed description
The treatment of age-related macular degeneration (AMD), the leading cause of blindness in the developed world, is undergoing a revolution. Intraocular injections of medications that can shut down the rapidly destructive "wet" form of the disease have changed this form to a chronic illness. However, vision is still lost. For the early forms of AMD, progression to the advanced "wet" and "dry" forms and severe vision loss is impeded but not stopped by current therapies of oral antioxidants. Thus, a better understanding of early AMD is needed to discover its root causes and provide treatment before irreparable damage is done.
The most important, highest-risk, and least understood form of early AMD is "reticular macular disease" (RMD). RMD is associated with significant progression to advanced AMD, both wet and dry. The lesions of RMD are well seen on the advanced retinal imaging techniques of spectral domain optical coherence tomography (SD-OCT) and scanning laser ophthalmoscopy (SLO). On SLO, RMD presents a pox-like pattern of dark defects SD-OCT provides high-resolution cross-sectional images of the retina, where RMD is seen as a collection of cholesterol-containing deposits, and the choroid, an essential blood supply of the retina, which is thinned and may be damaged in RMD. A unified explanation of these facets of RMD is lacking.
Regarding AMD and systemic diseases, the association between stroke, heart attack and AMD has been studied, but with some conflicting findings. For example, a relationship with heart attack has been established in patients less than age 75, but not in older patients. Where does RMD fit in? At present, no one knows. However, the known facts are these: RMD is associated with decreased longevity, which is not the case with other early forms of AMD. This could happen if RMD and systemic vascular disease co-exist. Finally, there is the very high proportion of women relative to men among older patients with RMD, about 85%. Women develop heart disease later than men and survive heart disease a decade longer on average. It is possible that these diseases both begin earlier in life, with more men dying before reaching older ages and demonstrating RMD. The research team submitting this proposal has preliminary data suggesting that this is in fact the case.
In a small group of subjects 50-75 years old, RMD was detected in a significant proportion of those with CAD compared to those without. Furthermore, in this younger group, the ratio of men to women in the RMD group was equal. The team proposes a large-scale initiative to provide definitive answers to these questions, in collaboration with expert cardiologists and neurologists to document vascular status unequivocally, and utilizing the most advanced retinal imaging available for the detection of RMD. This could lead to greater understanding of all three, stroke, heart attack and AMD, and ultimately better treatment, providing much needed relief to suffering patients and relief to the healthcare burden of an aging population.
- Being tested
- Blood draw
- Medical subject headings
- Macular Degeneration, Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawGenetic
Blood samples are collected for genetic analysis, looking specifically at serum lipids and the inflammatory biomarker hs-CRP.
| Study group | Role | What they receive |
|---|---|---|
| RMD+ Patients | Age-related macular degeneration patients with reticular macular disease Receives: Genetic: Blood draw | |
| RMD- Patients | Age-related macular degeneration patients without reticular macular disease Receives: Genetic: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of CAD+ patients in RMD+ Patients
Rate of coronary artery disease in age-related macular disease patients with reticular macular disease
Measured: 6 months
Proportion of CAD+ patients in RMD- Patients
Rate of coronary artery disease in age-related macular disease patients without reticular macular disease
Measured: 6 months
Secondary outcomes (5)
Evaluation of CAD risk factors as predictors of RMD status
Investigating the relationship between AMD/RMD to cardiac risk factors such as tobacco use, hyperlipidemia, elevated C-Reactive protein an inflammatory biomarker, and hypertension.
Measured: 6 months
Correlation of lipid panels with RMD status
Measuring the total cholesterol in blood, the standard cholesterol test (called a "lipid panel") measures three specific kinds of fat: Low-density lipoproteins (LDL). High-density lipoproteins (HDL). Triglycerides.
Measured: 6 months
Correlation of the C-Reactive Protein as an inflammatory biomarker with RMD status
High sensitivity CRP (hsCRP) blood tests able to measure down to 0.3 mg/L which is necessary in risk assessment for vascular disease.
Measured: 6 months
Correlation of imaging features with RMD status
Correlation of presence of soft drusen, geographic atrophy or choroidal neovascularization status in fellow eye, if present, with RMD status
Measured: 6 months
Correlation of genetic markers with CFHY402H and CFHrs1410996 genotypes, adjusting for AMD grade. These phenotypes may be a marker of genetic susceptibility for patients with RMD status.
High sensitivity RMD genetic blood test for markers with RMD status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start2 Aug 2019
- Primary completion31 Jan 2020 (estimated)
- Study completion20 Dec 2020 (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 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R. Theodore Smith, MD PhD, Study chair, New York Eye And Ear Infirmary of Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087356
- Sponsor's protocol ID
- IRB-19-01872
- Status last verified
- Sep 2019
- First submitted
- 9 Jul 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomson RJ, Chazaro J, Otero-Marquez O, Ledesma-Gil G, Tong Y, Coughlin AC, Teibel ZR, Alauddin S, Tai K, Lloyd H, Scolaro M, Govindaiah A, Bhuiyan A, Dhamoon MS, Deobhakta A, Narula J, Rosen RB, Yannuzzi LA, Freund KB, Smith RT. SUBRETINAL DRUSENOID DEPOSITS AND SOFT DRUSEN: Are They Markers for Distinct Retinal Diseases? Retina. 2022 Jul 1;42(7):1311-1318. doi: 10.1097/IAE.0000000000003460.
PubMed 35213528
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Macular Degeneration (AMD) and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04087356
- Acronym / sponsor ID
- IRB-19-01872
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 12 Sep 2019 (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 purpose of this research study is to investigate the link between age-related macular degeneration (AMD or ARMD) and coronary artery disease (CAD). Age-related macular degeneration is a medical condition which may result in blurred or no vision in the center of vision. Coronary artery disease is a blockage of one or more arteries that supply blood to the heart. The study will specifically look at the macular changes that occur in the retina, which is the sensory membrane that lines the inner surface at the back of the eyeball, and the relationship between coronary heart disease and the risk factors.
Detailed description
The treatment of age-related macular degeneration (AMD), the leading cause of blindness in the developed world, is undergoing a revolution. Intraocular injections of medications that can shut down the rapidly destructive "wet" form of the disease have changed this form to a chronic illness. However, vision is still lost. For the early forms of AMD, progression to the advanced "wet" and "dry" forms and severe vision loss is impeded but not stopped by current therapies of oral antioxidants. Thus, a better understanding of early AMD is needed to discover its root causes and provide treatment before irreparable damage is done.
The most important, highest-risk, and least understood form of early AMD is "reticular macular disease" (RMD). RMD is associated with significant progression to advanced AMD, both wet and dry. The lesions of RMD are well seen on the advanced retinal imaging techniques of spectral domain optical coherence tomography (SD-OCT) and scanning laser ophthalmoscopy (SLO). On SLO, RMD presents a pox-like pattern of dark defects SD-OCT provides high-resolution cross-sectional images of the retina, where RMD is seen as a collection of cholesterol-containing deposits, and the choroid, an essential blood supply of the retina, which is thinned and may be damaged in RMD. A unified explanation of these facets of RMD is lacking.
Regarding AMD and systemic diseases, the association between stroke, heart attack and AMD has been studied, but with some conflicting findings. For example, a relationship with heart attack has been established in patients less than age 75, but not in older patients. Where does RMD fit in? At present, no one knows. However, the known facts are these: RMD is associated with decreased longevity, which is not the case with other early forms of AMD. This could happen if RMD and systemic vascular disease co-exist. Finally, there is the very high proportion of women relative to men among older patients with RMD, about 85%. Women develop heart disease later than men and survive heart disease a decade longer on average. It is possible that these diseases both begin earlier in life, with more men dying before reaching older ages and demonstrating RMD. The research team submitting this proposal has preliminary data suggesting that this is in fact the case.
In a small group of subjects 50-75 years old, RMD was detected in a significant proportion of those with CAD compared to those without. Furthermore, in this younger group, the ratio of men to women in the RMD group was equal. The team proposes a large-scale initiative to provide definitive answers to these questions, in collaboration with expert cardiologists and neurologists to document vascular status unequivocally, and utilizing the most advanced retinal imaging available for the detection of RMD. This could lead to greater understanding of all three, stroke, heart attack and AMD, and ultimately better treatment, providing much needed relief to suffering patients and relief to the healthcare burden of an aging population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RMD+ Patients | – | Genetic: Blood drawAge-related macular degeneration patients with reticular macular disease |
| RMD- Patients | – | Genetic: Blood drawAge-related macular degeneration patients without reticular macular disease |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AMD with and without RMD
Key inclusion criteria (7 listed)
- Clinical diagnosis of age-related macular degeneration in at least one eye.
- Patients can have unilateral, but not bilateral CNV. In the case of unilateral CNV, the eye without the CNV will be the study eye.
- Age greater than 50
- Willing and able to comply with clinic visit and study-related procedures
- Provide signed informed consent
Key exclusion criteria (3 listed)
- Bilateral CNV
- Other retinal degenerations and retinal vascular diseases such as diabetic retinopathy or macular edema, prior retinal surgery
- Pregnant, lactating, or currently expecting a child
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 |
|---|---|---|
| Blood drawBlood samples are collected for genetic analysis, looking specifically at serum lipids and the inflammatory biomarker hs-CRP. | Genetic | RMD+ Patients, RMD- Patients |
Primary outcome
Proportion of CAD+ patients in RMD+ Patients
Time frame: 6 months
Rate of coronary artery disease in age-related macular disease patients with reticular macular disease
Proportion of CAD+ patients in RMD- Patients
Time frame: 6 months
Rate of coronary artery disease in age-related macular disease patients without reticular macular disease
5 secondary outcomes
Evaluation of CAD risk factors as predictors of RMD status
Time frame: 6 months
Correlation of lipid panels with RMD status
Time frame: 6 months
Correlation of the C-Reactive Protein as an inflammatory biomarker with RMD status
Time frame: 6 months
Correlation of imaging features with RMD status
Time frame: 6 months
Correlation of genetic markers with CFHY402H and CFHrs1410996 genotypes, adjusting for AMD grade. These phenotypes may be a marker of genetic susceptibility for patients with RMD status.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Derived from this study: PubMed 35213528Thomson RJ, Chazaro J, Otero-Marquez O, Ledesma-Gil G, Tong Y, Coughlin AC, Teibel ZR, Alauddin S, Tai K, Lloyd H, Scolaro M, Govindaiah A, Bhuiyan A, Dhamoon MS, Deobhakta A, Narula J, Rosen RB, Yannuzzi LA, Freund KB, Smith RT. SUBRETINAL DRUSENOID DEPOSITS AND SOFT DRUSEN: Are They Markers for Distinct Retinal Diseases? Retina. 2022 Jul 1;42(7):1311-1318. doi: 10.1097/IAE.0000000000003460.
- 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.
R. Theodore Smith, MD PhD study chair
New York Eye And Ear Infirmary of Mount Sinai
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 and Coronary Artery Disease, run by The New York Eye & Ear Infirmary 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R. Theodore Smith, MD PhD (212-9794579, rolandtheodore.smith@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of CAD+ patients in RMD+ Patients (time frame: 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 NCT04087356, 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 12 Sep 2019.