Evolution and Risk Factors Associated With Geographic Atrophy Progression

Completed

• Conditions: Geographic Atrophy

• Registration Number: NCT01694095
• Lead Sponsor: Institut de la Macula y la Retina

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 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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2012-09-22
• Study First Submitted QC: 2012-09-22
• Study First Posted: 2012-09-26
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Institut de la màcula i de la retina; 🇪🇸 Barcelona, Spain