- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02308215
Retinal Therapy Guided by 3D OCT Image Analysis
August 28, 2019 updated by: Michael Abramoff
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52246
- University of Iowa Hospitals Dept of Ophthalmology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 120 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The proposed research will be carried out in patients diagnosed with Choroidal Neovascularization associated with AMD selected from retina care clinic.
Description
Inclusion Criteria:
- fundoscopically confirmed AMD and patient eligible for treatment with anti-VEGF
Exclusion Criteria:
- Patients with a CNV due to other causes (OHS, trauma)
- eyes that have been previously treated for CNV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measure central retinal layer thickness in µms.
Time Frame: one year
|
one year
|
|
Measure amount of fluid in the retina in µms.
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael D Abramoff, MD, PhD, University of Iowa
- Principal Investigator: Milan Sonka, MS, PhD, University of Iowa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
July 5, 2018
Study Completion (Actual)
July 5, 2018
Study Registration Dates
First Submitted
November 13, 2014
First Submitted That Met QC Criteria
December 1, 2014
First Posted (Estimate)
December 4, 2014
Study Record Updates
Last Update Posted (Actual)
August 30, 2019
Last Update Submitted That Met QC Criteria
August 28, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201003712
- 1R01EY019112-01A2 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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