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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jordi Mones, Institut de la Macula y la Retina
ClinicalTrials.gov Identifier:
NCT01694095
First received: September 22, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition
Geographic Atrophy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characterization of Geographic Atrophy Progression in Patients With Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Institut de la Macula y la Retina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Exploratory analysis, either in the main publication or in another paper


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with geographic atrophy

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with geographic atrophy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694095

Locations
Spain
Institut de la màcula i de la retina
Barcelona, Spain, 08017
Sponsors and Collaborators
Institut de la Macula y la Retina
Investigators
Principal Investigator: Jordi Monés, MD, PhD Institut de la màcula i de la retina
  More Information

Publications:
Responsible Party: Jordi Mones, MD, PhD, Institut de la Macula y la Retina
ClinicalTrials.gov Identifier: NCT01694095     History of Changes
Other Study ID Numbers: GAIN-002-10-2010
Study First Received: September 22, 2012
Last Updated: August 5, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Institut de la Macula y la Retina:
Geographic atrophy, prognosis, risk factors, natural history

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014