Age-related Macular DegenerationGALLEY2NCT01464710
Genetic Assessment of Early to Late Macular Degeneration Study
An observational study of Age-related Macular Degeneration, run by Henry Ferreyra at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- How many people
- 170 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2008to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Subjects with any other progressive retinal disease that may impair the physician's ability to assess the severity of AMD
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, San Diego
La Jolla, California, 92093
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
California Retina Consultants
Santa Barbara, California, 93108
About this study
Official title: Genetic Assessment of Early to Late macuLar dEgeneration studY 2
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.
Read the 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.
- Conditions
- Age-related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the allele frequency for patients that progress to bilateral advanced AMD in the study eye
Measured: 5 years
Secondary outcomes (1)
To determine the allele frequency for patients that do not progress to bilateral advanced AMD in the study eye.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startApr 2008
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ferreyra
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Henry Ferreyra, University of California, San Diego
- Investigators
- Henry Ferreyra, M.D, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464710
- Sponsor's protocol ID
- 080585
- Acronym
- GALLEY2
- Status last verified
- Jun 2019
- First submitted
- 31 Oct 2011
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data not available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Assessment of Early to Late macuLar dEgeneration studY 2
- ClinicalTrials.gov ID
- NCT01464710
- Acronym / sponsor ID
- GALLEY2 / 080585
- Conditions
- Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Henry FerreyraUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2008
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects with any other progressive retinal disease that may impair the physician's ability to assess the severity of AMD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the allele frequency for patients that progress to bilateral advanced AMD in the study eye
Time frame: 5 years
1 secondary outcome
To determine the allele frequency for patients that do not progress to bilateral advanced AMD in the study eye.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Individual participant dataSharing planned: No. Data not available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Ferreyra, M.D study chair
University of California, San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Macular Degeneration, run by Henry Ferreyra at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the allele frequency for patients that progress to bilateral advanced AMD in the study eye (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.