Age-related Macular DegenerationNCT01115387
GARM II: A Study on the Genetics of Age-related Maculopathy
An observational study of Age-related Macular Degeneration and Age-related Maculopathy, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
The original study (GARM I) has been conducted for more than 18 years at the University of Pittsburgh Medical Center (UPMC). GARM II is a nationwide research study about age-related macular degeneration in the next generation of adults (49 to 65 years old). Read more about this study
- Who is it for?
- Ages 49 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration, Age-related Maculopathy
- What is being tested?
- Observational-1 and Observational-2
- How many people
- 603 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Oct 2011to Mar 2027
- Phase
- Observational
- 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 49 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nationwide study
Who may be able to join
- Individuals should have an email account and access to the Internet in order to use the website for this study. Individuals who are unfamiliar or physically challenged with using computers may have another person assist them with reviewing messages, questions and entering information and making inquiries.
- ARM at-risk individuals between the ages of 49 to 65 years old who have at least one parent either deceased or alive with diagnosis of macular degeneration. This group includes the "third generation children" of our original GARM study.
- Individuals between the ages of 49 to 65 years old who are either a spouse or partner of an ARM at-risk adult (those individuals described above with a parent diagnosed with ARM).
- Individuals who have vision loss from ARM and a known family history of ARM (at least a brother, sister, or a parent). These individuals should have at least one at-risk child between the ages of 49 to 65 years old who is willing to participate in this study.
Who cannot join
- Inability to give informed consent. Adaptations will be provided to allow those who are unable to read because of vision loss to participate in the informed consent process.(Proxy)
- For the at risk individuals and their spouses/partners, they will be excluded if they do not have access and the ability to use a computer that is connected to the Internet.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jules Stein Eye Institute, Dept. of Ophthalmology David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Genetics of Age Related Maculopathy
The original study (GARM I) has been conducted for more than 18 years at the University of Pittsburgh Medical Center (UPMC). GARM II is a nationwide research study about age-related macular degeneration in the next generation of adults (49 to 65 years old). The purpose of this study is to identify the hereditary and exposure risk factors that lead to the development of ARM (Age related maculopathy).
Participants will communicate with the research staff through a protected and confidential website and use this website to complete a number of questionnaires during the course of the study (see below). For genetic analyses, the participants will mail in easily self-collected saliva samples in special containers. Eye photographs and eye health records are sent to the research center from local sources through the Internet. Individuals are not expected to come to UCLA in order to participate.
Read more
https://jseiclinres.jsei.ucla.edu/garm/
Participants will be expected to answer questionnaires or surveys about medical history, ocular history and visual symptoms, family history, smoking, dietary supplements and light exposure.
Read the detailed description
Age-related macular degeneration (ARM) is a major cause of vision loss in the elderly. It is thought that smoking and diet may contribute to the risk of developing the condition but it is clear that heredity plays a major role. Variations in two genes, CFH and HTRA1/ARMS2, have been found to strongly contribute to the risk of developing ARM, but there are additional genes that influence a person's chances of having this condition and how they will progress to vision loss. We are investigating these genetic variations that contribute to ARM so that we can eventually understand the causes of this complex condition. We study the genetic variations (SNPs) that are shared among ARM-affected individuals within families as well as compare the frequencies of genetic variations in ARM-affected individuals with those in unaffected persons who are matched in age, gender, and exposures. We are conducting studies with the DNA from our previous cohort of research participants as well as developing a prospective study of high-risk family members and their spouses to evaluate genetic risks and presymptomatic retinal changes. Our long-term goals are to develop new preventive therapies that can slow or halt the development of this disease and to be able to provide these treatments to those who are at greatest risk before they experience vision-threatening changes.
The goal of this study (GARM II) is to determine how the combination of genetic, dietary, health and exposure factors such as light, diet, and smoking contributes to one's risk of developing this condition. This is not a treatment study and does not involve any preventive therapies or direct treatments of ARM. We aim to find some insights for future preventive strategies through a group of people who are at a higher than normal risk for developing ARM (because of their family history) and their partners who represent the risk in the general population. Because ARM is a complex disease and is affected by many factors, we also want to know how other medical conditions may be associated or not with this eye condition.
Participants will communicate with the research staff through a protected, HIPAA-compliant and confidential website and use this website to complete a number of questionnaires during the course of the study. For genetic analyses, the participants will mail in easily self-collected saliva samples in special containers. Eye photographs and eye health records are sent to the research center from local sources through the Internet. Individuals are not expected to come to UCLA in order to participate.
https://jseiclinres.jsei.ucla.edu/garm/
- Being tested
- Observational-1, Observational-2
- Keywords
- Age-related macular degeneration, AMD, Genetic risk, Environmental risk factors, Complex genetic disorder, Age-related maculopathy, Risk modeling, Smoking, Light exposure, Sleep apnea, Fundus Photography, Macula, Drusen, Wet AMD, Dry AMD, Geographic atrophy, Vitamins & supplements
- Medical subject headings
- Macular Degeneration, Smoking, Sleep Apnea Syndromes, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational-1Other
Multiple questionnaires detailing family history, medical history, visual symptoms, smoking, environmental and dietary exposures.
Prospective photography of the retina to detect early ARM-related changes A saliva or blood sample for genetic testing.
Observational-2Other
A limited number of questionnaires and prior clinical documentation from eye care professionals of eye status with respect to ARM.
No prospective retina photographs but ongoing follow-up for reported changes in ARM status.
A saliva or blood sample for genetic testing.
| Study group | Role | What they receive |
|---|---|---|
| ARM at risk individuals | A group of 1,500 participants (from 49 to 65 years old) who have at least one parent with age related maculopathy.
These individuals with ARM-affected parents and relatives have a substantially higher risk (6-12 fold) of developing ARM than the general population. They will be followed prospectively with fundus photography every two years and questionnaires (distributed over six month intervals) to assess external risks for ARM development in order to investigate genotype-phenotype correlations of early onset clinical features of ARM. Receives: Other: Observational-1 | |
| Partners/Spouses of ARM at risk individuals | A group of 1,500 participants (from 49 to 65 years old) who are the spouses/partners of individuals with ARM affected parents.
We will invite the partners or spouses to participate in order to compare their risk of developing ARM with those individuals with an increased risk of ARM based on a positive family history. Receives: Other: Observational-1 | |
| ARM affected individuals and relatives. | Individuals who have experienced vision loss from ARM and have at least one brother or sister who also has experienced vision loss from ARM can participate in the study. They also need to have at least one adult child (from 49 to 65 years old) who wishes to participate in this study.
We will allow for additional recruitment to compensate for additional family members (such as parents, aunts and uncles) who wish to participate as well as to address potential drop out and those who may be deemed ineligible based on review of their medical and/or eye records. As many as 4000 individuals in this group will be allowed to enroll. Receives: Other: Observational-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and prevalence of retinal findings associated with early (and more advanced) age-related maculopathy in the study cohorts.
The primary outcome measure is the presence or absence of early retinal changes with age-related maculopathy in order to develop and test a model which combines genetic, environmental and dietary risk factors to predict which at risk individuals are most likely to develop signs of age-related maculopathy within the study period.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study start6 Oct 2011
- Primary completionFeb 2016
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Jules Stein Eye Institute, University of Pittsburgh, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Michael B. Gorin, University of California, Los Angeles
- Investigators
- Michael B Gorin, MD, PhD, Principal investigator, Jules Stein Eye Institute, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115387
- Sponsor's protocol ID
- 08-11-008
- Other IDs
- 5R01EY009859
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2010
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Jakobsdottir J, Gorin MB, Conley YP, Ferrell RE, Weeks DE. Interpretation of genetic association studies: markers with replicated highly significant odds ratios may be poor classifiers. PLoS Genet. 2009 Feb;5(2):e1000337. doi: 10.1371/journal.pgen.1000337. Epub 2009 Feb 6.
PubMed 19197355Jakobsdottir J, Conley YP, Weeks DE, Ferrell RE, Gorin MB. C2 and CFB genes in age-related maculopathy and joint action with CFH and LOC387715 genes. PLoS One. 2008 May 21;3(5):e2199. doi: 10.1371/journal.pone.0002199.
PubMed 18493315Tikellis G, Sun C, Gorin MB, Klein R, Klein BE, Larsen EK, Siscovick DS, Hubbard LD, Wong TY. Apolipoprotein e gene and age-related maculopathy in older individuals: the cardiovascular health study. Arch Ophthalmol. 2007 Jan;125(1):68-73. doi: 10.1001/archopht.125.1.68.
PubMed 17210854Gorin MB. A clinician's view of the molecular genetics of age-related maculopathy. Arch Ophthalmol. 2007 Jan;125(1):21-9. doi: 10.1001/archopht.125.1.21.
PubMed 17210848Conley YP, Jakobsdottir J, Mah T, Weeks DE, Klein R, Kuller L, Ferrell RE, Gorin MB. CFH, ELOVL4, PLEKHA1 and LOC387715 genes and susceptibility to age-related maculopathy: AREDS and CHS cohorts and meta-analyses. Hum Mol Genet. 2006 Nov 1;15(21):3206-18. doi: 10.1093/hmg/ddl396. Epub 2006 Sep 25.
PubMed 17000705Jakobsdottir J, Conley YP, Weeks DE, Mah TS, Ferrell RE, Gorin MB. Susceptibility genes for age-related maculopathy on chromosome 10q26. Am J Hum Genet. 2005 Sep;77(3):389-407. doi: 10.1086/444437. Epub 2005 Jul 26.
PubMed 16080115Gorin MB. The coming of age for age-related macular degeneration genetics. Ophthalmic Genet. 2005 Jun;26(2):57-9. doi: 10.1080/13816810590969914. No abstract available.
PubMed 16020307Conley YP, Thalamuthu A, Jakobsdottir J, Weeks DE, Mah T, Ferrell RE, Gorin MB. Candidate gene analysis suggests a role for fatty acid biosynthesis and regulation of the complement system in the etiology of age-related maculopathy. Hum Mol Genet. 2005 Jul 15;14(14):1991-2002. doi: 10.1093/hmg/ddi204. Epub 2005 Jun 1.
PubMed 15930014Gorin MB. A new vision for age-related macular degeneration. Eur J Hum Genet. 2005 Jul;13(7):793-4. doi: 10.1038/sj.ejhg.5201431. No abstract available.
PubMed 15856069Weeks DE, Conley YP, Tsai HJ, Mah TS, Schmidt S, Postel EA, Agarwal A, Haines JL, Pericak-Vance MA, Rosenfeld PJ, Paul TO, Eller AW, Morse LS, Dailey JP, Ferrell RE, Gorin MB. Age-related maculopathy: a genomewide scan with continued evidence of susceptibility loci within the 1q31, 10q26, and 17q25 regions. Am J Hum Genet. 2004 Aug;75(2):174-89. doi: 10.1086/422476. Epub 2004 May 27.
PubMed 15168325Conley YP, Gorin MB. The genetics of age-related macular degeneration. Medsurg Nurs. 2003 Aug;12(4):238-41, 259.
PubMed 14515603Weeks DE, Conley YP, Tsai HJ, Mah TS, Rosenfeld PJ, Paul TO, Eller AW, Morse LS, Dailey JP, Ferrell RE, Gorin MB. Age-related maculopathy: an expanded genome-wide scan with evidence of susceptibility loci within the 1q31 and 17q25 regions. Am J Ophthalmol. 2001 Nov;132(5):682-92. doi: 10.1016/s0002-9394(01)01214-4.
PubMed 11704029
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Age Related Maculopathy
- ClinicalTrials.gov ID
- NCT01115387
- Acronym / sponsor ID
- 08-11-008
- Keywords
- Age-related macular degeneration, AMD, Genetic risk, Environmental risk factors, Complex genetic disorder, Age-related maculopathy, Risk modeling, Smoking
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 603 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Jules Stein Eye Institute, University of Pittsburgh, National Eye Institute (NEI)
- Study start
- 6 Oct 2011 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 May 2010 (estimated)
- 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 original study (GARM I) has been conducted for more than 18 years at the University of Pittsburgh Medical Center (UPMC). GARM II is a nationwide research study about age-related macular degeneration in the next generation of adults (49 to 65 years old). The purpose of this study is to identify the hereditary and exposure risk factors that lead to the development of ARM (Age related maculopathy).
Participants will communicate with the research staff through a protected and confidential website and use this website to complete a number of questionnaires during the course of the study (see below). For genetic analyses, the participants will mail in easily self-collected saliva samples in special containers. Eye photographs and eye health records are sent to the research center from local sources through the Internet. Individuals are not expected to come to UCLA in order to participate.
https://jseiclinres.jsei.ucla.edu/garm/
Participants will be expected to answer questionnaires or surveys about medical history, ocular history and visual symptoms, family history, smoking, dietary supplements and light exposure.
Detailed description
Age-related macular degeneration (ARM) is a major cause of vision loss in the elderly. It is thought that smoking and diet may contribute to the risk of developing the condition but it is clear that heredity plays a major role. Variations in two genes, CFH and HTRA1/ARMS2, have been found to strongly contribute to the risk of developing ARM, but there are additional genes that influence a person's chances of having this condition and how they will progress to vision loss. We are investigating these genetic variations that contribute to ARM so that we can eventually understand the causes of this complex condition. We study the genetic variations (SNPs) that are shared among ARM-affected individuals within families as well as compare the frequencies of genetic variations in ARM-affected individuals with those in unaffected persons who are matched in age, gender, and exposures. We are conducting studies with the DNA from our previous cohort of research participants as well as developing a prospective study of high-risk family members and their spouses to evaluate genetic risks and presymptomatic retinal changes. Our long-term goals are to develop new preventive therapies that can slow or halt the development of this disease and to be able to provide these treatments to those who are at greatest risk before they experience vision-threatening changes.
The goal of this study (GARM II) is to determine how the combination of genetic, dietary, health and exposure factors such as light, diet, and smoking contributes to one's risk of developing this condition. This is not a treatment study and does not involve any preventive therapies or direct treatments of ARM. We aim to find some insights for future preventive strategies through a group of people who are at a higher than normal risk for developing ARM (because of their family history) and their partners who represent the risk in the general population. Because ARM is a complex disease and is affected by many factors, we also want to know how other medical conditions may be associated or not with this eye condition.
Participants will communicate with the research staff through a protected, HIPAA-compliant and confidential website and use this website to complete a number of questionnaires during the course of the study. For genetic analyses, the participants will mail in easily self-collected saliva samples in special containers. Eye photographs and eye health records are sent to the research center from local sources through the Internet. Individuals are not expected to come to UCLA in order to participate.
https://jseiclinres.jsei.ucla.edu/garm/
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM at risk individuals | – | Other: Observational-1A group of 1,500 participants (from 49 to 65 years old) who have at least one parent with age related maculopathy. These individuals with ARM-affected parents and relatives have a substantially higher risk (6-12 fold) of developing ARM than the general population. They will be followed prospectively with fundus photography every two years and questionnaires (distributed over six month intervals) to assess external risks for ARM development in order to investigate genotype-phenotype correlations of early onset clinical features of ARM. |
| Partners/Spouses of ARM at risk individuals | – | Other: Observational-1A group of 1,500 participants (from 49 to 65 years old) who are the spouses/partners of individuals with ARM affected parents. We will invite the partners or spouses to participate in order to compare their risk of developing ARM with those individuals with an increased risk of ARM based on a positive family history. |
| ARM affected individuals and relatives. | – | Other: Observational-2Individuals who have experienced vision loss from ARM and have at least one brother or sister who also has experienced vision loss from ARM can participate in the study. They also need to have at least one adult child (from 49 to 65 years old) who wishes to participate in this study. We will allow for additional recruitment to compensate for additional family members (such as parents, aunts and uncles) who wish to participate as well as to address potential drop out and those who may be deemed ineligible based on review of their medical and/or eye records. As many as 4000 individuals in this group will be allowed to enroll. |
Who may qualify
- Ages
- 49 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nationwide study
Key inclusion criteria (4 listed)
- Individuals should have an email account and access to the Internet in order to use the website for this study. Individuals who are unfamiliar or physically challenged with using computers may have another person assist them with reviewing messages, questions and entering information and making inquiries.
- ARM at-risk individuals between the ages of 49 to 65 years old who have at least one parent either deceased or alive with diagnosis of macular degeneration. This group includes the "third generation children" of our original GARM study.
- Individuals between the ages of 49 to 65 years old who are either a spouse or partner of an ARM at-risk adult (those individuals described above with a parent diagnosed with ARM).
- Individuals who have vision loss from ARM and a known family history of ARM (at least a brother, sister, or a parent). These individuals should have at least one at-risk child between the ages of 49 to 65 years old who is willing to participate in this study.
Key exclusion criteria (2 listed)
- Inability to give informed consent. Adaptations will be provided to allow those who are unable to read because of vision loss to participate in the informed consent process.(Proxy)
- For the at risk individuals and their spouses/partners, they will be excluded if they do not have access and the ability to use a computer that is connected to the Internet.
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 |
|---|---|---|
| Observational-1Multiple questionnaires detailing family history, medical history, visual symptoms, smoking, environmental and dietary exposures. Prospective photography of the retina to detect early ARM-related changes A saliva or blood sample for genetic testing. | Other | ARM at risk individuals, Partners/Spouses of ARM at risk individuals |
| Observational-2A limited number of questionnaires and prior clinical documentation from eye care professionals of eye status with respect to ARM. No prospective retina photographs but ongoing follow-up for reported changes in ARM status. A saliva or blood sample for genetic testing. | Other | ARM affected individuals and relatives. |
Primary outcome
The incidence and prevalence of retinal findings associated with early (and more advanced) age-related maculopathy in the study cohorts.
Time frame: 5 years
The primary outcome measure is the presence or absence of early retinal changes with age-related maculopathy in order to develop and test a model which combines genetic, environmental and dietary risk factors to predict which at risk individuals are most likely to develop signs of age-related maculopathy within the study period.
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 7 Nov 2023.
- Background: PubMed 19197355Jakobsdottir J, Gorin MB, Conley YP, Ferrell RE, Weeks DE. Interpretation of genetic association studies: markers with replicated highly significant odds ratios may be poor classifiers. PLoS Genet. 2009 Feb;5(2):e1000337. doi: 10.1371/journal.pgen.1000337. Epub 2009 Feb 6.
- Background: PubMed 18493315Jakobsdottir J, Conley YP, Weeks DE, Ferrell RE, Gorin MB. C2 and CFB genes in age-related maculopathy and joint action with CFH and LOC387715 genes. PLoS One. 2008 May 21;3(5):e2199. doi: 10.1371/journal.pone.0002199.
- Background: PubMed 17210854Tikellis G, Sun C, Gorin MB, Klein R, Klein BE, Larsen EK, Siscovick DS, Hubbard LD, Wong TY. Apolipoprotein e gene and age-related maculopathy in older individuals: the cardiovascular health study. Arch Ophthalmol. 2007 Jan;125(1):68-73. doi: 10.1001/archopht.125.1.68.
- Background: PubMed 17210848Gorin MB. A clinician's view of the molecular genetics of age-related maculopathy. Arch Ophthalmol. 2007 Jan;125(1):21-9. doi: 10.1001/archopht.125.1.21.
- Background: PubMed 17000705Conley YP, Jakobsdottir J, Mah T, Weeks DE, Klein R, Kuller L, Ferrell RE, Gorin MB. CFH, ELOVL4, PLEKHA1 and LOC387715 genes and susceptibility to age-related maculopathy: AREDS and CHS cohorts and meta-analyses. Hum Mol Genet. 2006 Nov 1;15(21):3206-18. doi: 10.1093/hmg/ddl396. Epub 2006 Sep 25.
- Background: PubMed 16080115Jakobsdottir J, Conley YP, Weeks DE, Mah TS, Ferrell RE, Gorin MB. Susceptibility genes for age-related maculopathy on chromosome 10q26. Am J Hum Genet. 2005 Sep;77(3):389-407. doi: 10.1086/444437. Epub 2005 Jul 26.
- Background: PubMed 16020307Gorin MB. The coming of age for age-related macular degeneration genetics. Ophthalmic Genet. 2005 Jun;26(2):57-9. doi: 10.1080/13816810590969914. No abstract available.
- Background: PubMed 15930014Conley YP, Thalamuthu A, Jakobsdottir J, Weeks DE, Mah T, Ferrell RE, Gorin MB. Candidate gene analysis suggests a role for fatty acid biosynthesis and regulation of the complement system in the etiology of age-related maculopathy. Hum Mol Genet. 2005 Jul 15;14(14):1991-2002. doi: 10.1093/hmg/ddi204. Epub 2005 Jun 1.
- Background: PubMed 15856069Gorin MB. A new vision for age-related macular degeneration. Eur J Hum Genet. 2005 Jul;13(7):793-4. doi: 10.1038/sj.ejhg.5201431. No abstract available.
- Background: PubMed 15168325Weeks DE, Conley YP, Tsai HJ, Mah TS, Schmidt S, Postel EA, Agarwal A, Haines JL, Pericak-Vance MA, Rosenfeld PJ, Paul TO, Eller AW, Morse LS, Dailey JP, Ferrell RE, Gorin MB. Age-related maculopathy: a genomewide scan with continued evidence of susceptibility loci within the 1q31, 10q26, and 17q25 regions. Am J Hum Genet. 2004 Aug;75(2):174-89. doi: 10.1086/422476. Epub 2004 May 27.
- Background: PubMed 14515603Conley YP, Gorin MB. The genetics of age-related macular degeneration. Medsurg Nurs. 2003 Aug;12(4):238-41, 259.
- Background: PubMed 11704029Weeks DE, Conley YP, Tsai HJ, Mah TS, Rosenfeld PJ, Paul TO, Eller AW, Morse LS, Dailey JP, Ferrell RE, Gorin MB. Age-related maculopathy: an expanded genome-wide scan with evidence of susceptibility loci within the 1q31 and 17q25 regions. Am J Ophthalmol. 2001 Nov;132(5):682-92. doi: 10.1016/s0002-9394(01)01214-4.
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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.
Michael B Gorin, MD, PhD principal investigator
Jules Stein Eye Institute, UCLA
2 sites 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 Age-related Maculopathy, run by University of California, Los Angeles at 2 sites 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 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
The incidence and prevalence of retinal findings associated with early (and more advanced) age-related maculopathy in the study cohorts. (time frame: 5 years). 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 NCT01115387, which also lists 12 linked publications.
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 7 Nov 2023.