Age-Related Macular DegenerationNCT02308215
Retinal Therapy Guided by 3D OCT Image Analysis
An observational study of Age-Related Macular Degeneration and Choroidal Neovascularization, run by Michael Abramoff at 1 site in United States.
Trial summary
The main purpose is to find a better way to predict the timing of treatments given to patients with Wet Age-related macular degeneration using image analysis. Read more about this study
- Who is it for?
- Ages 45 to 120 years
- Conditions the study is for
- Age-Related Macular Degeneration, Choroidal Neovascularization
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 5 Jul 2018
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The proposed research will be carried out in patients diagnosed with Choroidal Neovascularization associated with AMD selected from retina care clinic.
Who may be able to join
- fundoscopically confirmed AMD and patient eligible for treatment with anti-VEGF
Who cannot join
- Patients with a CNV due to other causes (OHS, trauma)
- eyes that have been previously treated for CNV
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals Dept of Ophthalmology
Iowa City, Iowa, 52246
About this study
The main purpose is to find a better way to predict the timing of treatments given to patients with Wet Age-related macular degeneration using image analysis.
Read the detailed description
The study focuses on making better use of advanced three-dimensional imaging and analysis to allow physicians to know when a treatment is being effective and thus not overuse it. The study will examine how 3-D optical coherence tomography and related image analysis can be used to assess changes in the macula and retina of patients' eyes. These changes can reveal how well a person is responding to anti-VEGF treatment and thus help doctors provide proper treatment timing and care.
- Keywords
- Retina, AMD, OCT
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure central retinal layer thickness in µms.
Measured: one year
Measure amount of fluid in the retina in µms.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJul 2010
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Abramoff
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor-investigator, Michael Abramoff, University of Iowa
- Investigators
- Michael D Abramoff, MD, PhD, Principal investigator, University of IowaMilan Sonka, MS, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308215
- Sponsor's protocol ID
- 201003712
- Other IDs
- 1R01EY019112-01A2
- Status last verified
- Aug 2019
- First submitted
- 13 Nov 2014
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Therapy Guided by 3D OCT Image Analysis
- ClinicalTrials.gov ID
- NCT02308215
- Acronym / sponsor ID
- 201003712
- Keywords
- Retina, AMD, OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Michael AbramoffUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jul 2010
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 4 Dec 2014 (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 main purpose is to find a better way to predict the timing of treatments given to patients with Wet Age-related macular degeneration using image analysis.
Detailed description
The study focuses on making better use of advanced three-dimensional imaging and analysis to allow physicians to know when a treatment is being effective and thus not overuse it. The study will examine how 3-D optical coherence tomography and related image analysis can be used to assess changes in the macula and retina of patients' eyes. These changes can reveal how well a person is responding to anti-VEGF treatment and thus help doctors provide proper treatment timing and care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The proposed research will be carried out in patients diagnosed with Choroidal Neovascularization associated with AMD selected from retina care clinic.
Key inclusion criteria (1 listed)
- fundoscopically confirmed AMD and patient eligible for treatment with anti-VEGF
Key exclusion criteria (2 listed)
- Patients with a CNV due to other causes (OHS, trauma)
- eyes that have been previously treated for CNV
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
Measure central retinal layer thickness in µms.
Time frame: one year
Measure amount of fluid in the retina in µms.
Time frame: one year
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 30 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Michael D Abramoff, MD, PhD principal investigator
University of Iowa
Milan Sonka, MS, PhD principal investigator
University of Iowa
1 site 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 and Choroidal Neovascularization, run by Michael Abramoff at 1 site 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 1 inclusion and 2 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 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Measure central retinal layer thickness in µms. (time frame: one year). The study lists 2 primary outcomes in all. 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 30 Aug 2019.