Non-exudative Age-related Macular Degeneration (NEAMD)

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: NCT01712841
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : April 5, 2018
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Brief Summary:

Age-related macular degeneration (AMD) is the most prevalent cause of vision loss in developed countries and is often discussed in terms of the "dry" and the "wet" forms. The "wet" form of AMD is the more advanced form of the disease and is responsible for 80% of the legal blindness in AMD. Treatment options include a promising class of biologics called anti-vascular endothelial growth factors, as well as photodynamic therapy and laser surgery. These therapies can slow further vision loss, but cannot achieve recovery of lost vision. The "wet" form of AMD is always preceded by the "dry" form. Therefore, it is reasonable to expect that the early detection and treatment of the "dry" form may help reduce vision loss or progression to the more damaging "wet" form. Unfortunately, symptoms appear only in advanced stages of the "dry" form. As light sensitive cells in the macula breakdown in a process called geographic atrophy, the patient may notice blurred central vision.

OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging, except that OCT measures the intensity of reflected light rather than acoustical waves.

This study aims is to use OCT technology to compare how the retinal anatomy and blood flow differ within three severity groupings of non-exudative age-related macular degeneration (NEAMD).

Condition or disease
Non-exudative Age-related Macular Degeneration

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Prospective Study Examining Patients With Non-exudative Age-related Macular Degeneration (NEAMD) of Different Severity
Actual Study Start Date : October 2012
Actual Primary Completion Date : January 18, 2018
Actual Study Completion Date : January 18, 2018

Resource links provided by the National Library of Medicine

Severe NEAMD
Presence of definite central or noncentral geographic atrophy within 3000 microns of the foveal center
Moderate/Intermediate NEAMD
Presence of large drusen (>125µ) and pigmentary changes without geographic atrophy
Mild/Early NEAMD
Presence of small or medium drusen without geographic atrophy

Primary Outcome Measures :
  1. Number of patients with severe NEAMD who have changes in retinal anatomy/blood flow compared with patients with mild and moderate NEAMD [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals between the ages of 60 and 85 years of age presenting to the Retina Service within the Department of Ophthalmology at the Casey Eye Institute of Oregon Health & Science University with signs and symptoms of non-exudative AMD.

Inclusion Criteria:

  • Presence of mild, moderate or severe NEAMD.
  • Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.
  • Vision better than 20/200

Exclusion Criteria:

  • Inability to give informed consent.
  • Inability to maintain stable fixation for OCT imaging.
  • A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • A concurrent ocular pathology that may contribute to vision loss (e.g., CNV, glaucoma, visually significant cataract, optic neuropathy, diabetic retinopathy, history of retinal surgery) or interfere with acquisition of high-quality images
  • Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
  • An ocular condition is present that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
  • Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
  • Unable to ambulate and take tram from clinic to where OCT is located

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): NCT01712841

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Thomas S Hwang, MD Oregon Health and Science University

Responsible Party: David Huang, Thomas S. Hwang, MD, Associate Professor of Ophthalmology, Oregon Health and Science University Identifier: NCT01712841     History of Changes
Other Study ID Numbers: OHSU IRB #00008749
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by David Huang, Oregon Health and Science University:
Age-related macular degeneration
Optical coherenece tomography
Blood flow

Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases