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Completed

NCT Number: NCT01694095

Evolution and Risk Factors Associated With Geographic Atrophy Progression

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.

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Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de la màcula i de la retina

Barcelona, 08017, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both sexes
  • 50 years of age or older
  • Uni or bilateral areas of geographic atrophy in the macula (as defined as areas devoid of retinal pigment epithelium measuring at least 0.5 disk areas on a 35º fundus photograph centered on field 2) secondary to age-related macular degeneration
  • Willing to provide Informed consent

Exclusion criteria

  • Other causes of geographic atrophy aside from age-related macular degeneration (ie, drug induced, central serous chorioretinopathy)
  • Prior history of wet age-related macular degeneration
  • Other significant concomitant macular diseases (ie, significant epiretinal membrane, stage II-IV macular hole)
  • Previous treatment with macular laser photocoagulation, photodynamic therapy, antiangiogenic drugs or other treatments for wet age-related macular degeneration
  • Intraocular surgery aside from phacoemulsification
  • Inability to measure the full extent of the area of atrophy on a 35º fundus autofluorescence image centered on field 2
  • Areas of geographic atrophy in direct contact with peripapillary areas of atrophy

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. Median/mean change in best-corrected visual acuity as measured with an Early Treatment Diabetic Retinopathy Study chart

    Time frame: From baseline to last follow-up

  2. Percentage of eyes developing new choroidal neovascularization in the study eye as evaluated with fluorescein angiography and spectral-domain optical coherence tomography

    Time frame: From baseline to last follow-up

  3. 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

    Principal component analysis will be used to reduce the number of independent variables to increase, if possible, the power of the study to detect an association

Sponsors and collaborators

Lead sponsor

Institut de la Macula y la Retina

Other

Registry information

Official study title

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

Acronym: GAIN

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2012
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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