NCT02779686

Brief Summary

This study is being conducted to compare two different genetic tests developed to determine an individuals risk of developing serious vision threatening complications from age-related macular degeneration (ARMD).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

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

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

May 13, 2016

Last Update Submit

October 3, 2016

Conditions

Age-Related Macular Degeneration (ARMD)

Keywords

Macular DegenerationGenetic testingAge-Related Macular degenerationAge-Related Maculopathies

Outcome Measures

Primary Outcomes (2)

  • Risk score from RetnaGene

    Risk score assigned after genetic analysis of a buccal swab by the RetnaGene (Sequenom) genetic test.

    Day 1

  • Risk score from Macula Risk

    Risk score assigned after genetic analysis of a buccal swab by the Macula Risk genetic test.

    Day 1

Study Arms (2)

ARMD Free

Patient free of ARMD on clinical examination

ARMD Positive

Patients with evidence of ARMD on clinical examination

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Caucasian patients over the age of 60

You may qualify if:

  • Caucasian race
  • Age \>/= 60 years
  • Patient's written informed consent
  • Ability to comply with the protocol procedures

You may not qualify if:

  • Race other than Caucasian
  • Age \< 60 years
  • Macular or retinal pathology other than ARMD
  • Known hypersensitivity to any drug included in the treatment protocol
  • Any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

Related Publications (3)

  • Seddon JM, Reynolds R, Maller J, Fagerness JA, Daly MJ, Rosner B. Prediction model for prevalence and incidence of advanced age-related macular degeneration based on genetic, demographic, and environmental variables. Invest Ophthalmol Vis Sci. 2009 May;50(5):2044-53. doi: 10.1167/iovs.08-3064. Epub 2008 Dec 30.

    PMID: 19117936BACKGROUND

  • Hageman GS, Gehrs K, Lejnine S, Bansal AT, Deangelis MM, Guymer RH, Baird PN, Allikmets R, Deciu C, Oeth P, Perlee LT. Clinical validation of a genetic model to estimate the risk of developing choroidal neovascular age-related macular degeneration. Hum Genomics. 2011 Jul;5(5):420-40. doi: 10.1186/1479-7364-5-5-420.

    PMID: 21807600BACKGROUND

  • Zanke B, Hawken S, Carter R, Chow D. A genetic approach to stratification of risk for age-related macular degeneration. Can J Ophthalmol. 2010 Feb;45(1):22-7. doi: 10.3129/i09-209.

    PMID: 20130705BACKGROUND

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Nancy Holekamp, MD

    Pepose Vision Institute

    PRINCIPAL INVESTIGATOR

  • Mathew MacCumber, MD, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

  • Arghavan Almony, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 20, 2016

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)