NCT01666821

Brief Summary

To investigate pathomorphological and functional variations of choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative AMD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

Enrollment Period

4.3 years

First QC Date

August 14, 2012

Last Update Submit

August 14, 2012

Conditions

Keywords

macular degeneration; choroidal neovascularization

Outcome Measures

Primary Outcomes (1)

  • change of the early and intermediate-stage AMD

    Drusen with unclear boundaries and obvious pigment proliferation, with hypofluorescence around drusens seen on FFA and a slight small arch field located in the retinal pigment epithelium (RPE)/choriocapillary layer (CCL) on OCT indicated exudative AMD.

    May 2004-September 2008

Study Arms (1)

early and intermediate-stage AMD

Follow-up observation was implemented in whose fundus examination show lesions in the early and intermediate-stage AMD

Other: Follow-up observation

Interventions

a epidemiologic survey of ocular diseases in an adult population (\>45 years old) in Youyi Street, Baoshan District, Shanghai, China, conducted to determine the prevalence of AMD in the region. To this end, we utilized routine ocular examinations

early and intermediate-stage AMD

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

recruited 1813 adults citizens aged above 45 years by probability sampling from the Youyi Street, Baoshan District, Shanghai, China for an epidemiologic survey. All participants gave written informed consent, and this study was approved by the local Ethics Committee in accordance with the Helsinki Declaration.

You may qualify if:

  • adults citizens aged above 45 years

You may not qualify if:

  • lost samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youyi Street

Shanghai, Baoshan District, 201900, China

Location

MeSH Terms

Conditions

Geographic AtrophyWet Macular DegenerationRetinal DrusenChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • zhao jie, master

    Director of ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of ophthalmology, Shuguang hospital(Baoshan branch),Shanghai University of TCM

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 16, 2012

Study Start

May 1, 2004

Primary Completion

September 1, 2008

Study Completion

January 1, 2009

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations