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

NCT03433885 | Unknown DMC

• 1 other identifier: kyk20175
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Macular Pigment Optical Density

Keywords

macular pigment optical density (MPOD); Age-related Macular Degeneration (AMD); drusen; Chroidal neovascularization (CNV); lutein; zeaxanthin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Association between age and incident Advanced AMD

  baseline

• Association between gender and incident Advanced AMD

  baseline

• Association between Baseline AMD grade and incident Advanced AMD

  baseline

• Association between cigarette smoking and incident Advanced AMD

  baseline

• Association between body mass index (BMI) and incident Advanced AMD

  baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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 ）

Sponsors & Collaborators

• The Eye Hospital of Wenzhou Medical University: lead

Study Sites (1)

The eye hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (11)

• 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.

  PMID: 15640920 BACKGROUND

• 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.

  PMID: 24625378 BACKGROUND

• 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.

  PMID: 25190650 BACKGROUND

• 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. doi: 10.1016/s0161-6420(95)30846-9.

  PMID: 9097791 BACKGROUND

• 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. doi: 10.1016/s0161-6420(02)01055-2.

  PMID: 12045049 BACKGROUND

• 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.

  PMID: 21444116 BACKGROUND

• Schmitz-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.

  PMID: 15557456 BACKGROUND

• 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. doi: 10.1093/ajcn/87.5.1521.

  PMID: 18469279 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2007.03.083. Epub 2007 Jul 30.

  PMID: 17664009 BACKGROUND

• Lovie-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.

  PMID: 16255688 BACKGROUND

• 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.

  PMID: 19752423 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Xiaoling Liu, MD

  The Eye Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Zhou, MD

CONTACT

86-577-88068855; zhourongmoon@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief in retina center

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 15, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

CN (1)