NCT02088229

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

March 7, 2014

Last Update Submit

January 25, 2016

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Dark adaptation (AdaptRx)

    Rod intercept (minutes)

    12 Months

Secondary Outcomes (1)

  • Optical coherence tomography

    12 Months

Other Outcomes (7)

  • Fluorescein angiography

    12 months

  • Lipofuscin fundus autofluorescence

    12 Months

  • Color photographs

    12 Months

  • +4 more other outcomes

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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;

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Study Officials

  • Grant Comer, M.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Edward T and Ellen K Dryer Career Development Professor of Ophthalmology and Visual Sciences and Assistant Professor of Ophthalmology and Visual Sciences, Medical School

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 14, 2014

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

US(1)