Clinical Trial: Evolution and Risk Factors Associated With Geographic Atrophy Progression

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Characterization of Geographic Atrophy Progression in Patients With Age-related Macular Degeneration

Brief Summary: Age-related macular degeneration is one of the leading causes of blindness worldwide. The factors that induce the progression of geographic atrophy, the advanced form of dry age-related macular degeneration, remain poorly understood. The aims of this study are to describe the natural history of geographic atrophy and identify potential risk factors associated with a faster spread of atrophy that may be used to develop rational therapies.

Detailed Summary:

Age-related macular degeneration is the leading cause of blindness in developed countries. Geographic atrophy is the advanced form of dry age-related macular degeneration, and currently has no effective therapy. Little is known about the risk factors that drive the progression of geographic atrophy, and yet they are crucial to understand the mechanisms of the disease. Therefore, the identification of risk factors associated with a faster spread of atrophy may help contribute to identify the causes of the disease and, ultimately, to develop new therapeutic strategies to manage the disorder.

The current prospective, observational, natural history study has the following objectives:

  • Describe the natural history of geographic atrophy in anatomic and visual terms
  • Identify risk factors associated with a faster enlargement of atrophy

The main hypothesis is that lipofuscin accumulation at the borders of atrophy as seen with fundus autofluorescence imaging is associated with a faster progression of the disease.


Sponsor: Institut de la Macula y la Retina

Current Primary Outcome: Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2 [ Time Frame: From baseline to last follow-up ]

For measures related to change in the area of atrophy, a multivariable model will be fit and will include as an independent variable (amongst other presumed risk factors) fundus autofluorescence patterns


Original Primary Outcome: Median change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2 [ Time Frame: From baseline to year 3 ]

Current Secondary Outcome: Median change in area of geographic atrophy as measured in square root of mm2 with fundus autofluorescence on a 30º image centered on field 2 [ Time Frame: From baseline to last follow-up ]

Exploratory analysis, either in the main publication or in another paper


Original Secondary Outcome: Median change in area of geographic atrophy as measured in square root of mm2 with fundus autofluorescence on a 30º image centered on field 2 [ Time Frame: From baseline to year 3 ]

Information By: Institut de la Macula y la Retina

Dates:
Date Received: September 22, 2012
Date Started: December 2009
Date Completion:
Last Updated: March 23, 2015
Last Verified: March 2015