Evolution and Risk Factors Associated With Geographic Atrophy Progression (GAIN)

March 23, 2015 updated by: Jordi Mones, Institut de la Macula y la Retina

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08017
        • Institut de la Macula i de la Retina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with geographic atrophy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with geographic atrophy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to last follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to last follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to last follow-up
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
From baseline to last follow-up
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
From baseline to last follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de la Macula y la Retina

Investigators

  • Principal Investigator: Jordi Monés, MD, PhD, Institut de la Macula i de la Retina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 22, 2012

First Submitted That Met QC Criteria

September 22, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAIN-002-10-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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