Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-27 @ 2:58 AM
Study NCT ID:
NCT01694095
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2012-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution and Risk Factors Associated With Geographic Atrophy Progression
Sponsor:
Institut de la Macula y la Retina
Organization:
Study Overview
Official Title:
Characterization of Geographic Atrophy Progression in Patients With Age-related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAIN
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: