Clinical trial NCT03433885: Wenzhou Dry Age-related Macular Degeneration (AMD) Progression Study
Official title: Progression of Dry Age-related Macular Degeneration (AMD): Association With Macular Pigment Optical Density (MPOD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Macular Pigment Optical Density
Keywords: macular pigment optical density (MPOD)
Age-related Macular Degeneration (AMD)
drusen
Chroidal neovascularization (CNV)
lutein
zeaxanthin
Lead sponsor: The Eye Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 300
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

Eligibility 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 ）

Primary outcomes:
measure: Association between changes of macular pigment optical density (MPOD) level and incidence rates of advanced AMD
timeFrame: from baseline to month 36
Secondary outcomes:
measure: Association between age and incident Advanced AMD
timeFrame: baseline
measure: Association between gender and incident Advanced AMD
timeFrame: baseline
measure: Association between Baseline AMD grade and incident Advanced AMD
timeFrame: baseline
measure: Association between cigarette smoking and incident Advanced AMD
timeFrame: baseline
measure: Association between body mass index (BMI) and incident Advanced AMD
timeFrame: baseline
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The eye hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: The Eye Hospital of Wenzhou Medical University
name: Xiaoling Liu, MD
role: PRINCIPAL_INVESTIGATOR
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