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

Macular Pigment Optical Density Clinical Trial

Official title:

Progression of Dry Age-related Macular Degeneration (AMD): Association With Macular Pigment Optical Density (MPOD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03433885
• Other study ID #: kyk20175
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2021
• Source: The Eye Hospital of Wenzhou Medical University
• Contact: Rong Zhou, MD
• Phone: 86-577-88068855
• Email: zhourongmoon[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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 )

Related Conditions & MeSH terms

• Macular Degeneration
• Macular Pigment Optical Density

Locations

Country	Name	City	State
China	The eye hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (11)

Huang 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. — View Citation

Johnson 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. — View Citation

Lovie-Kitchin J, Feigl B. Assessment of age-related maculopathy using subjective vision tests. Clin Exp Optom. 2005 Sep;88(5):292-303. Review. — View Citation

Mitchell 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. Review. — View Citation

Mitchell 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. Erratum in: Ophthalmology 2002 Sep;109(9):1588. — View Citation

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. — View Citation

Schmitz-Valckenberg S, Bültmann 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. Erratum in: Invest Ophthalmol Vis Sci. 2005 Jan;46(1):7. — View Citation

Tan 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. Epub 2007 Jul 30. — View Citation

Yang 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. — View Citation

Ye 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. — View Citation

Ying 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from baseline to month 36
Secondary	Association between age and incident Advanced AMD	controlling for age (70 years or older versus younger than 70)	baseline
Secondary	Association between gender and incident Advanced AMD		baseline
Secondary	Association between Baseline AMD grade and incident Advanced AMD	Baseline AMD grade was de?ned 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.	baseline
Secondary	Association between cigarette smoking and incident Advanced AMD	cigarette smoking information was acquired by questionaires(never, past, or current); .	baseline
Secondary	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 )	baseline