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Completed

NCT Number: NCT02088229

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

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).

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dark adaptation (AdaptRx)

    Time frame: 12 Months

    Rod intercept (minutes)

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. Lipofuscin fundus autofluorescence

    Time frame: 12 Months

    Index of retinal autofluorescence

  3. Color photographs

    Time frame: 12 Months

    Diabetic Retinopathy Disease Severity Scale

  4. Frequency Doubling Threshold visual field

    Time frame: 12 Months

    Mean deviation, pattern standard deviation

  5. Contrast sensitivity

    Time frame: 12 Months

    Log contrast sensitivity

  6. Photostress test

    Time frame: 12 Months

  7. Flavoprotein fluorescence

    Time frame: 12 Months

    Index of metabolic fluorescence, average intensity (grey scale unit (gsu)), average curve width (GSU), heterogeneity score

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 14, 2014
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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