Macular Pigment Optical DensityNCT03433885
Wenzhou Dry Age-related Macular Degeneration (AMD) Progression Study
An observational study of Macular Pigment Optical Density, run by The Eye Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
To evaluate the correlation between macular pigment optical density (MPOD) levels and risk of progression in patients with age-related macular degeneration Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Macular Pigment Optical Density
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2023
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese subjects aged 45 years and older living in the city of Wenzhou diagnosed with either CNV or dry AMD
Who may be able to join
- subject is diagnosed with either CNV, dry AMD
- 45 years of age or older
- provides signed and dated informed consent
Who cannot join
- Ocular condition in the study eye which may impact vision and confound study outcomes
- Presence of macular edema like retinal vascular diseases or diabetic retinopathy
- active inflammation ofr infection in the study eye
- high myopia（ ≥6D ）
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The eye hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Rong Zhou, MD
Xiaoling Liu, MD
About this study
Official title: Progression of Dry Age-related Macular Degeneration (AMD): Association With Macular Pigment Optical Density (MPOD)
To evaluate the correlation between macular pigment optical density (MPOD) levels and risk of progression in patients with age-related macular degeneration
Read the detailed description
Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly.[1] The disease is categorized into early, intermediate, or advanced stages based on the severity of symptoms. The advanced stage, including GA and CNV, involves central region of the retina, which leads to a gradual or rapid loss of photoreceptors and central vision.
The macular pigment (MP) consists of xanthophyll, which is formed from the yellow carotenoid lutein, zeaxanthin, and meso-zeaxanthin.These pigments play an important role in protecting the retina against oxidative stress through different mechanisms[6]. Many studies have shown a various association of AMD and MP.Blue Mountain Eye Study revealed low dietary intake of lutein and zeaxanthin is associated with a higher risk of AMD. However, dry and wet subtypes of AMD may have different etiologies and risk factors. Little is known whether longitudinal study of macular pigment optical density (MPOD) is related to AMD progression.
A comprehensive ophthalmologic examination including fundus photography,OCT and MPOD was performed at baseline, and semiannually thereafter for 3 years. Fundus reflectance (VISUCAM 500, reflectance of a single 460 nm wavelength) was used to measure the MPOD levels. Associated risk factors including body-mass index (BMI), smoking, diet, and cardiovascular diseases were documented. Drusen characteristics (size, type, area), pigmentary abnormalities (increased pigment, depigmentation, geographic atrophy), and presence of abnormalities characteristic of neovascular AMD were graded. For estimations of AMD progression , a 9-step severity scale that combines a 6-step drusen area scale with a 5-step pigmentary abnormality scale is used.
In this study, we are going to investigate a 3-year study of incidence and progression for AMD and associated risk factors, in a population-based cohort of Chinese aged 45 years and older living in the city of Wenzhou.
- Conditions
- Macular Pigment Optical Density
- Keywords
- macular pigment optical density (MPOD), Age-related Macular Degeneration (AMD), drusen, Chroidal neovascularization (CNV), lutein, zeaxanthin
- 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 group | Role | What they receive |
|---|---|---|
| Progressors | Progressors are those individuals with early or intermediate AMD at baseline who progress to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who progress to advanced AMD in both eyes. | |
| Nonprogressor | Nonprogressors are those individuals with early or intermediate AMD at baseline who do not progressed to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who do not progress to advanced AMD in fellow eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between changes of macular pigment optical density (MPOD) level and incidence rates of advanced AMD
Incident advanced AMD was evaluated based on the AMD grade at the end of the clinical trial with follow-up time of 3 years. Progressors were those individuals with early or intermediate AMD at baseline who progressed to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who progressed to advanced AMD in both eyes
Measured: from baseline to month 36
Secondary outcomes (5)
Association between age and incident Advanced AMD
controlling for age (70 years or older versus younger than 70)
Measured: baseline
Association between gender and incident Advanced AMD
Measured: baseline
Association between Baseline AMD grade and incident Advanced AMD
Baseline AMD grade was defined as AREDS category 1 in both eyes (essentially free of age-related macular abnormalities), category 2 in the worst eye (mild changes including multiple small drusen, nonextensive intermediate drusen, and/or pigment abnormalities), category 3 in the worst eye (at least one large drusen of at least 125µm diameter, extensive intermediate drusen, and/or noncentral geographic atrophy), category 4 in one eye (advanced AMD, either neovascular or central geographic atrophy, or visual loss due to AMD regardless of phenotype), or category 4 in both eyes.
Measured: baseline
Association between cigarette smoking and incident Advanced AMD
cigarette smoking information was acquired by questionaires(never, past, or current)
.
Measured: baseline
Association between body mass index (BMI) and incident Advanced AMD
BMI was calculated as the weight in kilograms divided by the square of the height in meters ( 25, 25-29.9, and 30 )
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Macular Pigment Optical DensityStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Eye Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Liu, The Eye Hospital of Wenzhou Medical University
- Investigators
- Xiaoling Liu, MD, Principal investigator, The Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433885
- Sponsor's protocol ID
- kyk20175
- Status last verified
- Feb 2021
- First submitted
- 30 Jan 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
PubMed 15640920Huang EJ, Wu SH, Lai CH, Kuo CN, Wu PL, Chen CL, Chen CY, King YC, Wu PC. Prevalence and risk factors for age-related macular degeneration in the elderly Chinese population in south-western Taiwan: the Puzih eye study. Eye (Lond). 2014 Jun;28(6):705-14. doi: 10.1038/eye.2014.55. Epub 2014 Mar 14.
PubMed 24625378Ye H, Zhang Q, Liu X, Cai X, Yu W, Yu S, Wang T, Lu W, Li X, Jin H, Hu Y, Kang X, Zhao P. Prevalence of age-related macular degeneration in an elderly urban chinese population in China: the Jiangning Eye Study. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6374-80. doi: 10.1167/iovs.14-14899.
PubMed 25190650Mitchell P, Smith W, Attebo K, Wang JJ. Prevalence of age-related maculopathy in Australia. The Blue Mountains Eye Study. Ophthalmology. 1995 Oct;102(10):1450-60. doi: 10.1016/s0161-6420(95)30846-9.
PubMed 9097791Mitchell P, Wang JJ, Foran S, Smith W. Five-year incidence of age-related maculopathy lesions: the Blue Mountains Eye Study. Ophthalmology. 2002 Jun;109(6):1092-7. doi: 10.1016/s0161-6420(02)01055-2.
PubMed 12045049Yang K, Liang YB, Gao LQ, Peng Y, Shen R, Duan XR, Friedman DS, Sun LP, Mitchell P, Wang NL, Wong TY, Wang JJ. Prevalence of age-related macular degeneration in a rural Chinese population: the Handan Eye Study. Ophthalmology. 2011 Jul;118(7):1395-401. doi: 10.1016/j.ophtha.2010.12.030. Epub 2011 Mar 27.
PubMed 21444116Schmitz-Valckenberg S, Bultmann S, Dreyhaupt J, Bindewald A, Holz FG, Rohrschneider K. Fundus autofluorescence and fundus perimetry in the junctional zone of geographic atrophy in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4470-6. doi: 10.1167/iovs.03-1311.
PubMed 15557456Johnson EJ, Chung HY, Caldarella SM, Snodderly DM. The influence of supplemental lutein and docosahexaenoic acid on serum, lipoproteins, and macular pigmentation. Am J Clin Nutr. 2008 May;87(5):1521-9. doi: 10.1093/ajcn/87.5.1521.
PubMed 18469279Tan JS, Wang JJ, Flood V, Rochtchina E, Smith W, Mitchell P. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41. doi: 10.1016/j.ophtha.2007.03.083. Epub 2007 Jul 30.
PubMed 17664009Lovie-Kitchin J, Feigl B. Assessment of age-related maculopathy using subjective vision tests. Clin Exp Optom. 2005 Sep;88(5):292-303. doi: 10.1111/j.1444-0938.2005.tb06713.x.
PubMed 16255688Ying GS, Maguire MG, Alexander J, Martin RW, Antoszyk AN; Complications of Age-related Macular Degeneration Prevention Trial Research Group. Description of the Age-Related Eye Disease Study 9-step severity scale applied to participants in the Complications of Age-related Macular Degeneration Prevention Trial. Arch Ophthalmol. 2009 Sep;127(9):1147-51. doi: 10.1001/archophthalmol.2009.189.
PubMed 19752423
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Dry Age-related Macular Degeneration (AMD): Association With Macular Pigment Optical Density (MPOD)
- ClinicalTrials.gov ID
- NCT03433885
- Acronym / sponsor ID
- kyk20175
- Conditions
- Macular Pigment Optical Density
- Keywords
- macular pigment optical density (MPOD), Age-related Macular Degeneration (AMD), drusen, Chroidal neovascularization (CNV), lutein, zeaxanthin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Eye Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Feb 2018 (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.
To evaluate the correlation between macular pigment optical density (MPOD) levels and risk of progression in patients with age-related macular degeneration
Detailed description
Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly.[1] The disease is categorized into early, intermediate, or advanced stages based on the severity of symptoms. The advanced stage, including GA and CNV, involves central region of the retina, which leads to a gradual or rapid loss of photoreceptors and central vision.
The macular pigment (MP) consists of xanthophyll, which is formed from the yellow carotenoid lutein, zeaxanthin, and meso-zeaxanthin.These pigments play an important role in protecting the retina against oxidative stress through different mechanisms[6]. Many studies have shown a various association of AMD and MP.Blue Mountain Eye Study revealed low dietary intake of lutein and zeaxanthin is associated with a higher risk of AMD. However, dry and wet subtypes of AMD may have different etiologies and risk factors. Little is known whether longitudinal study of macular pigment optical density (MPOD) is related to AMD progression.
A comprehensive ophthalmologic examination including fundus photography,OCT and MPOD was performed at baseline, and semiannually thereafter for 3 years. Fundus reflectance (VISUCAM 500, reflectance of a single 460 nm wavelength) was used to measure the MPOD levels. Associated risk factors including body-mass index (BMI), smoking, diet, and cardiovascular diseases were documented. Drusen characteristics (size, type, area), pigmentary abnormalities (increased pigment, depigmentation, geographic atrophy), and presence of abnormalities characteristic of neovascular AMD were graded. For estimations of AMD progression , a 9-step severity scale that combines a 6-step drusen area scale with a 5-step pigmentary abnormality scale is used.
In this study, we are going to investigate a 3-year study of incidence and progression for AMD and associated risk factors, in a population-based cohort of Chinese aged 45 years and older living in the city of Wenzhou.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressors | – | –Progressors are those individuals with early or intermediate AMD at baseline who progress to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who progress to advanced AMD in both eyes. |
| Nonprogressor | – | –Nonprogressors are those individuals with early or intermediate AMD at baseline who do not progressed to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who do not progress to advanced AMD in fellow eye. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese subjects aged 45 years and older living in the city of Wenzhou diagnosed with either CNV or dry AMD
Key inclusion criteria (3 listed)
- subject is diagnosed with either CNV, dry AMD
- 45 years of age or older
- provides signed and dated informed consent
Key exclusion criteria (4 listed)
- Ocular condition in the study eye which may impact vision and confound study outcomes
- Presence of macular edema like retinal vascular diseases or diabetic retinopathy
- active inflammation ofr infection in the study eye
- high myopia（ ≥6D ）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between changes of macular pigment optical density (MPOD) level and incidence rates of advanced AMD
Time frame: from baseline to month 36
Incident advanced AMD was evaluated based on the AMD grade at the end of the clinical trial with follow-up time of 3 years. Progressors were those individuals with early or intermediate AMD at baseline who progressed to advanced AMD during follow-up, and individuals with advanced AMD in one eye at baseline who progressed to advanced AMD in both eyes
5 secondary outcomes
Association between age and incident Advanced AMD
Time frame: baseline
Association between gender and incident Advanced AMD
Time frame: baseline
Association between Baseline AMD grade and incident Advanced AMD
Time frame: baseline
Association between cigarette smoking and incident Advanced AMD
Time frame: baseline
Association between body mass index (BMI) and incident Advanced AMD
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Background: PubMed 15640920Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
- Background: PubMed 24625378Huang EJ, Wu SH, Lai CH, Kuo CN, Wu PL, Chen CL, Chen CY, King YC, Wu PC. Prevalence and risk factors for age-related macular degeneration in the elderly Chinese population in south-western Taiwan: the Puzih eye study. Eye (Lond). 2014 Jun;28(6):705-14. doi: 10.1038/eye.2014.55. Epub 2014 Mar 14.
- Background: PubMed 25190650Ye H, Zhang Q, Liu X, Cai X, Yu W, Yu S, Wang T, Lu W, Li X, Jin H, Hu Y, Kang X, Zhao P. Prevalence of age-related macular degeneration in an elderly urban chinese population in China: the Jiangning Eye Study. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6374-80. doi: 10.1167/iovs.14-14899.
- Background: PubMed 9097791Mitchell P, Smith W, Attebo K, Wang JJ. Prevalence of age-related maculopathy in Australia. The Blue Mountains Eye Study. Ophthalmology. 1995 Oct;102(10):1450-60. doi: 10.1016/s0161-6420(95)30846-9.
- Background: PubMed 12045049Mitchell P, Wang JJ, Foran S, Smith W. Five-year incidence of age-related maculopathy lesions: the Blue Mountains Eye Study. Ophthalmology. 2002 Jun;109(6):1092-7. doi: 10.1016/s0161-6420(02)01055-2.
- Background: PubMed 21444116Yang K, Liang YB, Gao LQ, Peng Y, Shen R, Duan XR, Friedman DS, Sun LP, Mitchell P, Wang NL, Wong TY, Wang JJ. Prevalence of age-related macular degeneration in a rural Chinese population: the Handan Eye Study. Ophthalmology. 2011 Jul;118(7):1395-401. doi: 10.1016/j.ophtha.2010.12.030. Epub 2011 Mar 27.
- Background: PubMed 15557456Schmitz-Valckenberg S, Bultmann S, Dreyhaupt J, Bindewald A, Holz FG, Rohrschneider K. Fundus autofluorescence and fundus perimetry in the junctional zone of geographic atrophy in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4470-6. doi: 10.1167/iovs.03-1311.
- Background: PubMed 18469279Johnson EJ, Chung HY, Caldarella SM, Snodderly DM. The influence of supplemental lutein and docosahexaenoic acid on serum, lipoproteins, and macular pigmentation. Am J Clin Nutr. 2008 May;87(5):1521-9. doi: 10.1093/ajcn/87.5.1521.
- Background: PubMed 17664009Tan JS, Wang JJ, Flood V, Rochtchina E, Smith W, Mitchell P. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41. doi: 10.1016/j.ophtha.2007.03.083. Epub 2007 Jul 30.
- Background: PubMed 16255688Lovie-Kitchin J, Feigl B. Assessment of age-related maculopathy using subjective vision tests. Clin Exp Optom. 2005 Sep;88(5):292-303. doi: 10.1111/j.1444-0938.2005.tb06713.x.
- Background: PubMed 19752423Ying GS, Maguire MG, Alexander J, Martin RW, Antoszyk AN; Complications of Age-related Macular Degeneration Prevention Trial Research Group. Description of the Age-Related Eye Disease Study 9-step severity scale applied to participants in the Complications of Age-related Macular Degeneration Prevention Trial. Arch Ophthalmol. 2009 Sep;127(9):1147-51. doi: 10.1001/archophthalmol.2009.189.
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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.
Xiaoling Liu, MD principal investigator
The Eye Hospital of Wenzhou Medical University
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 Macular Pigment Optical Density, run by The Eye Hospital of Wenzhou Medical University at 1 site in China.
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 3 inclusion and 4 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 24 Feb 2021. 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 China. 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 Rong Zhou, MD (86-577-88068855, zhourongmoon@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between changes of macular pigment optical density (MPOD) level and incidence rates of advanced AMD (time frame: from baseline to month 36). 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 NCT03433885, which also lists 11 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 24 Feb 2021.