NCT00599846

Brief Summary

The objective of the 18-month trial is to evaluate the natural history of geographic atrophy by assessing the rate of progression of the geographic atrophic lesion over time.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

March 2, 2010

Status Verified

February 1, 2010

Enrollment Period

2 years

First QC Date

January 13, 2008

Last Update Submit

February 26, 2010

Conditions

Age-Related Macular DegenerationGeographic Atrophy

Keywords

age-related macular degenerationgeographic atrophy

Outcome Measures

Primary Outcomes (1)

  • GA progression rate using fundus autofluorescence

    From baseline

Secondary Outcomes (1)

  • GA progression rate using fundus photography

    From baseline

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients showing signs of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.

You may qualify if:

  • Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.

You may not qualify if:

  • Age related

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Steinberg JS, Auge J, Jaffe GJ, Fleckenstein M, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Longitudinal analysis of reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2013 Jun 10;54(6):4054-60. doi: 10.1167/iovs.12-11538.

    PMID: 23633663DERIVED

  • Mauschitz MM, Fonseca S, Chang P, Gobel AP, Fleckenstein M, Jaffe GJ, Holz FG, Schmitz-Valckenberg S; GAP Study Group. Topography of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2012 Jul 26;53(8):4932-9. doi: 10.1167/iovs.12-9711.

    PMID: 22661483DERIVED

  • Schmitz-Valckenberg S, Alten F, Steinberg JS, Jaffe GJ, Fleckenstein M, Mukesh BN, Hohman TC, Holz FG; Geographic Atrophy Progression (GAP) Study Group. Reticular drusen associated with geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Aug 24;52(9):5009-15. doi: 10.1167/iovs.11-7235.

    PMID: 21498612DERIVED

  • Schmitz-Valckenberg S, Fleckenstein M, Gobel AP, Hohman TC, Holz FG. Optical coherence tomography and autofluorescence findings in areas with geographic atrophy due to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Jan 5;52(1):1-6. doi: 10.1167/iovs.10-5619.

    PMID: 20688734DERIVED

MeSH Terms

Conditions

Macular DegenerationGeographic Atrophy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Patricia Zilliox

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2008

First Posted

January 24, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2009

Last Updated

March 2, 2010

Record last verified: 2010-02

Locations

US(1)