Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema

January 25, 2016 updated by: Grant Comer, University of Michigan

This longitudinal interventional case series will utilize the patients at the University of Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema. Baseline measures will be taken which include structural assessments such as circulatory capacity utilizing fluorescein angiography, in addition to retinal layer integrity and thickness using high resolution optical coherence tomography. Also, functional assessments such as visual acuity, contrast sensitivity, photostress recovery, dark adaptation, perimetry, and cellular fluorescence will be tested. Adverse events will be recorded and compared with historical controls to ensure that currently accepted interventions are safe. Finally, potential confounding variables for DME including those related to the eye, systemic factors, and patient demographics will be recorded to assess the influence of these variables on treatment response.

The primary objective is to develop hypotheses that might better explain the retinal structural (anatomical) and/or functional (physiological) mechanisms of visual impairment in eyes receiving treatment for diabetic macular edema (DME).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

35

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Kellogg Eye Center

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals undergoing treatment for diabetic macular edema at the University of Michigan W.K. Kellogg Eye Center.

Description

Inclusion Criteria:

  • Males and females age ≥ 18 years
  • DME involving the central fovea (≥325 micrometers central subfield thickness on Spectralis SD-OCT)
  • Scheduled to undergo treatment of DME with intravitreal bevacizumab or ranibizumab
  • Willing to sign informed consent, comply with study protocol requirements, and undergo at least 2.5 hours of testing per visit;

Exclusion Criteria:

  • Lens opacity ≥ grade 3 ARLNS on standard photographs
  • Incisional ophthalmic surgery of any kind within 4 months of study enrollment
  • Treatment for DME within the past 4 months
  • Active proliferative diabetic retinopathy
  • History of vitrectomy
  • Glaucoma
  • Uncontrolled hypertension (≥ 180 systolic or ≥ 110 diastolic on two successive measures)
  • Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the study
  • Females who are pregnant, lactating or breastfeeding at time of enrollment
  • Subjects with a history of a serious hypersensitivity reaction to treatment or components of the study assessment
  • History of any radiation in or around the eyes
  • History of visually significant non-diabetic retinopathy or choroidopathy (e.g. age-related macular degeneration, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy)
  • History of optic neuropathy
  • Neurological conditions that can impair vision (e.g. Parkinson's disease, multiple sclerosis, Alzheimer's disease)
  • Liver disease (e.g. cirrhosis, hepatitis)
  • History of small bowel surgery
  • Anticipated need for intravitreal triamcinolone injections
  • Dilated pupil diameter less than 6 millimeters
  • High myopia (refractive error spherical equivalent ≥ -6 diopters)
  • Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year trial
  • Participation in any interventional clinical study requiring IRB approval within 3 months of enrollment
  • Any findings deemed unacceptable by the Principal Investigator

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
Measure Description
Time Frame
Dark adaptation (AdaptRx)
Time Frame: 12 Months
Rod intercept (minutes)
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optical coherence tomography
Time Frame: 12 Months
Thickness of nerve fiber layer and ganglion cell layer, volume of intraretinal cysts, volume of subretinal fluid, central subfield thickness, thickness of choroid (enhanced depth imaging), status of vitreoretinal interface, presence of epiretinal membrane, status of inner segment/outer segment junction
12 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluorescein angiography
Time Frame: 12 months
Fluorescein transit time, foveal avascular zone (FAZ) greatest linear dimension, FAZ area, presence of perifoveal capillary loss, area of dye leakage, and microaneurysm density
12 months
Lipofuscin fundus autofluorescence
Time Frame: 12 Months
Index of retinal autofluorescence
12 Months
Color photographs
Time Frame: 12 Months
Diabetic Retinopathy Disease Severity Scale
12 Months
Frequency Doubling Threshold visual field
Time Frame: 12 Months
Mean deviation, pattern standard deviation
12 Months
Contrast sensitivity
Time Frame: 12 Months
Log contrast sensitivity
12 Months
Photostress test
Time Frame: 12 Months
12 Months
Flavoprotein fluorescence
Time Frame: 12 Months
Index of metabolic fluorescence, average intensity (grey scale unit (gsu)), average curve width (GSU), heterogeneity score
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Juvenile Diabetes Research Foundation

Investigators

  • Principal Investigator: Grant Comer, M.D., University of Michigan

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

September 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00064483

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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