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).
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Michigan
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Ann Arbor, Michigan, Forente stater, 48105
- Kellogg Eye Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dark adaptation (AdaptRx)
Tidsramme: 12 Months
|
Rod intercept (minutes)
|
12 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Optical coherence tomography
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fluorescein angiography
Tidsramme: 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
Tidsramme: 12 Months
|
Index of retinal autofluorescence
|
12 Months
|
|
Color photographs
Tidsramme: 12 Months
|
Diabetic Retinopathy Disease Severity Scale
|
12 Months
|
|
Frequency Doubling Threshold visual field
Tidsramme: 12 Months
|
Mean deviation, pattern standard deviation
|
12 Months
|
|
Contrast sensitivity
Tidsramme: 12 Months
|
Log contrast sensitivity
|
12 Months
|
|
Photostress test
Tidsramme: 12 Months
|
12 Months
|
|
|
Flavoprotein fluorescence
Tidsramme: 12 Months
|
Index of metabolic fluorescence, average intensity (grey scale unit (gsu)), average curve width (GSU), heterogeneity score
|
12 Months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Grant Comer, M.D., University of Michigan
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HUM00064483
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