Clinical trial NCT02088229: Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
Official title: Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2014-03-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals undergoing treatment for diabetic macular edema at the University of Michigan W.K. Kellogg Eye Center.

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Dark adaptation (AdaptRx)
timeFrame: 12 Months
Secondary outcomes:
measure: Optical coherence tomography
timeFrame: 12 Months
Other outcomes:
measure: Fluorescein angiography
timeFrame: 12 months
measure: Lipofuscin fundus autofluorescence
timeFrame: 12 Months
measure: Color photographs
timeFrame: 12 Months
measure: Frequency Doubling Threshold visual field
timeFrame: 12 Months
measure: Contrast sensitivity
timeFrame: 12 Months
measure: Photostress test
timeFrame: 12 Months
measure: Flavoprotein fluorescence
timeFrame: 12 Months
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Grant Comer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: