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Wenzhou Dry Age-related Macular Degeneration (AMD) Progression Study

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ClinicalTrials.gov Identifier: NCT03433885
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaoling Liu, The Eye Hospital of Wenzhou Medical University

Brief Summary:
To evaluate the correlation between macular pigment optical density (MPOD) levels and risk of progression in patients with age-related macular degeneration

Condition or disease
Macular Pigment Optical Density

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Progression of Dry Age-related Macular Degeneration (AMD): Association With Macular Pigment Optical Density (MPOD)
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Association between age and incident Advanced AMD [ Time Frame: baseline ]
    controlling for age (70 years or older versus younger than 70)

  2. Association between gender and incident Advanced AMD [ Time Frame: baseline ]
  3. Association between Baseline AMD grade and incident Advanced AMD [ Time Frame: baseline ]
    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.

  4. Association between cigarette smoking and incident Advanced AMD [ Time Frame: baseline ]

    cigarette smoking information was acquired by questionaires(never, past, or current)

    .


  5. Association between body mass index (BMI) and incident Advanced AMD [ Time Frame: baseline ]
    BMI was calculated as the weight in kilograms divided by the square of the height in meters ( 25, 25-29.9, and 30 )



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese subjects aged 45 years and older living in the city of Wenzhou diagnosed with either CNV or dry AMD
Criteria

Inclusion Criteria:

  • subject is diagnosed with either CNV, dry AMD
  • 45 years of age or older
  • provides signed and dated informed consent

Exclusion Criteria:

  • 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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433885


Contacts
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Contact: Rong Zhou, MD 86-577-88068855 zhourongmoon@163.com

Locations
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China, Zhejiang
The eye hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Rong Zhou, MD         
Principal Investigator: Xiaoling Liu, MD         
Sponsors and Collaborators
The Eye Hospital of Wenzhou Medical University
Investigators
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Principal Investigator: Xiaoling Liu, MD The Eye Hospital of Wenzhou Medical University
Publications:

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Responsible Party: Xiaoling Liu, Chief in retina center, The Eye Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03433885    
Other Study ID Numbers: kyk20175
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaoling Liu, The Eye Hospital of Wenzhou Medical University:
macular pigment optical density (MPOD)
Age-related Macular Degeneration (AMD)
drusen
Chroidal neovascularization (CNV)
lutein
zeaxanthin
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases