GAIN: Evolution and Risk Factors Associated With Geographic Atrophy Progression

Sponsor

Institut de la Macula y la Retina (Other)

Overall Status

Completed

CT.gov ID

NCT01694095

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

96 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Patients with geographic atrophy

Outcome Measures

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 [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 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 [From baseline to last follow-up]
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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jordi Mones, MD, PhD, Institut de la Macula y la Retina

ClinicalTrials.gov Identifier:

NCT01694095

Other Study ID Numbers:

GAIN-002-10-2010

First Posted:

Sep 26, 2012

Last Update Posted:

Mar 24, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Jordi Mones, MD, PhD, Institut de la Macula y la Retina

Geographic atrophy, prognosis, risk factors, natural history

Additional relevant MeSH terms:

Geographic Atrophy

Atrophy

Study Results

No Results Posted as of Mar 24, 2015