Viewing Study NCT01464710



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Last Modification Date: 2024-10-26 @ 10:43 AM
Study NCT ID: NCT01464710
Status: COMPLETED
Last Update Posted: 2019-06-21
First Post: 2011-10-31

Brief Title: Genetic Assessment of Early to Late Macular Degeneration Study
Sponsor: Henry Ferreyra
Organization: University of California San Diego

Study Overview

Official Title: Genetic Assessment of Early to Late macuLar dEgeneration studY 2
Status: COMPLETED
Status Verified Date: 2019-06
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: GALLEY2
Brief Summary: 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 drusen120 microns in the study eye and with either early AMD or advanced AMD in the non-study eye
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
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?: None