Genetic Assessment of Early to Late Macular Degeneration Study (GALLEY2)
The purpose of this study is to determine if polymorphisms at rs11200638 on HTRA1 and rs1061170 on CFH are associated with an accelerated progression to advanced AMD (wet AMD or GA) in patients with early AMD (soft confluent drusen>120 microns ) in the study eye, and with either early AMD or advanced AMD in the non-study eye.
Age-related Macular Degeneration
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Genetic Assessment of Early to Late macuLar dEgeneration studY 2|
- To determine the allele frequency for patients that progress to bilateral advanced AMD in the study eye [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To determine the allele frequency for patients that do not progress to bilateral advanced AMD in the study eye. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Specimen collected for genotype analysis.
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. To date, two major polymorphisms on the HTRA1 and CFH genes have been associated with AMD. Progression and vision loss need to be followed and treated promptly in order to preserve vision. This study will provide more information on the genetics of disease progression and may lead to future guidelines for patient follow-up and treatment.
This study consists of a blood draw and observation of eye conditions. Consented, enrolled patients will come in every four months as per standard of care. At each visit, visual acuity measurement, slit lamp exam, indirect ophthalmoscopy, fundus photos, and spectral domain optical coherence tomography will be performed. Every 8 months, or per standard of care, fluoroscein angiography will be performed. DNA extraction and genotyping will be performed, and correlations between HTRA1 and CFH genotypes and the progression to bilateral advanced AMD will be analyzed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464710
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|
|California Retina Consultants|
|Santa Barbara, California, United States, 93108|
|United States, Texas|
|Medical Center Ophthalmology Associates|
|San Antonio, Texas, United States, 78240|
|Principal Investigator:||Kang Zhang, MD, PhD||UCSD, Shiley Eye Center|