Retinal Therapy Guided by 3D OCT Image Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02308215
Recruitment Status : Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : August 2, 2018
National Eye Institute (NEI)
Information provided by (Responsible Party):
Michael Abramoff, University of Iowa

Brief 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.

Condition or disease
Age-Related Macular Degeneration Choroidal Neovascularization

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
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Retinal Therapy Guided by 3D OCT Image Analysis
Study Start Date : July 2010
Estimated Primary Completion Date : November 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Measure central retinal layer thickness in µms. [ Time Frame: one year ]
  2. Measure amount of fluid in the retina in µms. [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02308215

United States, Iowa
University of Iowa Hospitals Dept of Ophthalmology
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Michael Abramoff
National Eye Institute (NEI)
Principal Investigator: Michael D Abramoff, MD, PhD University of Iowa
Principal Investigator: Milan Sonka, MS, PhD University of Iowa

Responsible Party: Michael Abramoff, Professor, University of Iowa Identifier: NCT02308215     History of Changes
Other Study ID Numbers: 201003712
1R01EY019112-01A2 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Abramoff, University of Iowa:

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases