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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Michigan
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Grant Comer, University of Michigan
ClinicalTrials.gov Identifier:
NCT02088229
First received: March 7, 2014
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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).


Condition
Diabetic Macular Edema

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Dark adaptation (AdaptRx) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Rod intercept (minutes)


Secondary Outcome Measures:
  • Optical coherence tomography [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Fluorescein angiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Fluorescein transit time, foveal avascular zone (FAZ) greatest linear dimension, FAZ area, presence of perifoveal capillary loss, area of dye leakage, and microaneurysm density

  • Lipofuscin fundus autofluorescence [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Index of retinal autofluorescence

  • Color photographs [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Diabetic Retinopathy Disease Severity Scale

  • Frequency Doubling Threshold visual field [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Mean deviation, pattern standard deviation

  • Contrast sensitivity [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Log contrast sensitivity

  • Photostress test [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Flavoprotein fluorescence [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Index of metabolic fluorescence, average intensity (grey scale unit (gsu)), average curve width (GSU), heterogeneity score


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02088229

Contacts
Contact: Lindsay M Godsey, M.S. 734-936-9798 godseyli@med.umich.edu

Locations
United States, Michigan
Kellogg Eye Center Recruiting
Ann Arbor, Michigan, United States, 48105
Principal Investigator: Grant Comer, M.D.         
Sponsors and Collaborators
University of Michigan
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Grant Comer, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Grant Comer, Edward T and Ellen K Dryer Career Development Professor of Ophthalmology and Visual Sciences and Assistant Professor of Ophthalmology and Visual Sciences, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT02088229     History of Changes
Other Study ID Numbers: HUM00064483
Study First Received: March 7, 2014
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Diabetic Macular Edema

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014