Evolution and Risk Factors Associated With Geographic Atrophy Progression (GAIN)
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| ClinicalTrials.gov Identifier: NCT01694095 |
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Recruitment Status :
Completed
First Posted : September 26, 2012
Last Update Posted : March 24, 2015
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| Condition or disease |
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| Geographic Atrophy |
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 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 : | December 2009 |
| Actual Primary Completion Date : | August 2013 |
| Actual Study Completion Date : | August 2013 |
| Group/Cohort |
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| Patients with geographic atrophy |
- 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 ]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
- 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 ]Exploratory analysis, either in the main publication or in another paper
- 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 ]
- 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 ]
- 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 ]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
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694095
| Spain | |
| Institut de la màcula i de la retina | |
| Barcelona, Spain, 08017 | |
| Principal Investigator: | Jordi Monés, MD, PhD | Institut de la màcula i de la retina |
| 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: | September 26, 2012 Key Record Dates |
| Last Update Posted: | March 24, 2015 |
| Last Verified: | March 2015 |
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Geographic atrophy, prognosis, risk factors, natural history |
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Geographic Atrophy Atrophy Pathological Conditions, Anatomical Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases |