Genetic Assessment of Early to Late Macular Degeneration Study
GALLEY2
1 other identifier
observational
170
1 country
3
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 drusen\>120 microns ) in the study eye, and with either early AMD or advanced AMD in the non-study eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2008
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 31, 2011
CompletedFirst Posted
Study publicly available on registry
November 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJune 21, 2019
June 1, 2019
6.8 years
October 31, 2011
June 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the allele frequency for patients that progress to bilateral advanced AMD in the study eye
5 years
Secondary Outcomes (1)
To determine the allele frequency for patients that do not progress to bilateral advanced AMD in the study eye.
5 years
Eligibility Criteria
Subjects with a diagnosis of advanced AMD in one eye (either CNV or geographic atrophy) and soft confluent drusen in the study eye OR subjects with bilateral large soft drusen.
You may qualify if:
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 45 years
- Disease related considerations
- Subjects with a diagnosis of advanced AMD in one eye (either CNV or geographic atrophy) and soft confluent drusen in the study eye OR subjects with bilateral large soft drusen.
You may not qualify if:
- Subjects with any other progressive retinal disease that may impair the physician's ability to assess the severity of AMD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henry Ferreyralead
- Genentech, Inc.collaborator
Study Sites (3)
University of California, San Diego
La Jolla, California, 92093, United States
California Retina Consultants
Santa Barbara, California, 93108, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Biospecimen
Specimen collected for genotype analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Henry Ferreyra, M.D
University of California, San Diego
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 3, 2011
Study Start
April 1, 2008
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
June 21, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share
Data not available.