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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088229
• Other study ID #: HUM00064483
• Status: Completed
• Phase: N/A
• First received: March 7, 2014
• Last updated: January 25, 2016
• Start date: September 2012
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Locations

Country	Name	City	State
United States	Kellogg Eye Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fluorescein angiography	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	No
Other	Lipofuscin fundus autofluorescence	Index of retinal autofluorescence	12 Months	No
Other	Color photographs	Diabetic Retinopathy Disease Severity Scale	12 Months	No
Other	Frequency Doubling Threshold visual field	Mean deviation, pattern standard deviation	12 Months	No
Other	Contrast sensitivity	Log contrast sensitivity	12 Months	No
Other	Photostress test		12 Months	No
Other	Flavoprotein fluorescence	Index of metabolic fluorescence, average intensity (grey scale unit (gsu)), average curve width (GSU), heterogeneity score	12 Months	No
Primary	Dark adaptation (AdaptRx)	Rod intercept (minutes)	12 Months	No
Secondary	Optical coherence tomography	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	No