Evolution and Risk Factors Associated With Geographic Atrophy Progression

Geographic Atrophy Clinical Trial

— GAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694095
• Other study ID #: GAIN-002-10-2010
• Status: Completed
• Phase: N/A
• First received: September 22, 2012
• Last updated: March 23, 2015
• Start date: December 2009
• Est. completion date: August 2013

Study information

• Verified date: March 2015
• Source: Institut de la Macula y la Retina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Locations

Country	Name	City	State
Spain	Institut de la màcula i de la retina	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut de la Macula y la Retina

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Biarnés M, Forero CG, Arias L, Alonso J, Monés J. Reappraisal of geographic atrophy patterns seen on fundus autofluorescence using a latent class analysis approach. Invest Ophthalmol Vis Sci. 2014 Nov 18;55(12):8302-8. doi: 10.1167/iovs.13-13542. — View Citation

Biarnés M, Monés J, Trindade F, Alonso J, Arias L. Intra and interobserver agreement in the classification of fundus autofluorescence patterns in geographic atrophy secondary to age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2012 Apr; — View Citation

Monés J, Biarnés M, Trindade F, Arias L, Alonso J. Optical coherence tomography assessment of apparent foveal swelling in patients with foveal sparing secondary to geographic atrophy. Ophthalmology. 2013 Apr;120(4):829-36. doi: 10.1016/j.ophtha.2012.09.05 — View Citation

Monés J, Biarnés M, Trindade F. Hyporeflective wedge-shaped band in geographic atrophy secondary to age-related macular degeneration: an underreported finding. Ophthalmology. 2012 Jul;119(7):1412-9. doi: 10.1016/j.ophtha.2012.01.026. Epub 2012 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Median/mean change in best-corrected visual acuity as measured with an Early Treatment Diabetic Retinopathy Study chart		From baseline to last follow-up	No
Other	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	No
Other	Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2	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	No
Primary	Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2	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	No
Secondary	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	Exploratory analysis, either in the main publication or in another paper	From baseline to last follow-up	No