NCT02088229

Completed

Relating Retinal Structural and Functional Parameters to Vis...

University of Michigan Source

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Other study identifiers

Sponsor study identifier

HUM00064483

Study Type

observational

Actual enrollment (reported)

35

Locations

1 country

Sites

1

Timeline

Study Start

September 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 35 participants
Study completion date: July 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2012
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 7, 2014
Actual (reported)
First Posted
March 14, 2014
Actual (reported)
Primary Completion
June 2015
Actual (reported)
Study Completion
July 2015
Actual (reported)

Last Updated: January 26, 2016
Status Verified: January 2016
Last Update Submitted: 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

Sponsors & Collaborators

University of Michigan
Otherlead
Juvenile Diabetes Research Foundation
Othercollaborator

Study Sites (1)

Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Study Officials

Grant Comer, M.D.
University of Michigan
PRINCIPAL INVESTIGATOR

Enrollment

35 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

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A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study)

Phase 2Terminated

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Diabetic Macular Edema Treated With Ozurdex (DMEO)

Phase 2Completed

NCT01788475

Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery

Not ApplicableTerminated

NCT01945866

Phase II Combination Steroid and Anti-VEGF for Persistent DME

Phase 2Completed

NCT01982435

Safety and Efficacy of Ranibizumab for Diabetic Macular Edema

Phase 1/2Completed

NCT01627249

Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema

Phase 3Completed

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.

This date has not been verified as actual or estimated.

Primary Completion

June 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

Last Updated

January 26, 2016

Record last verified: 2016-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02088229
Data provider: ClinicalTrials.gov
Source updated: 2016-01-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:08 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (7)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations