Diabetic Macular EdemaNCT02088229
Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
An observational study of Diabetic Macular Edema, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals undergoing treatment for diabetic macular edema at the University of Michigan W.K. Kellogg Eye Center.
Who may be able to join
- 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;
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
Dark adaptation (AdaptRx)
Rod intercept (minutes)
Measured: 12 Months
Secondary outcomes (1)
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Grant Comer, University of Michigan
- Investigators
- Grant Comer, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088229
- Sponsor's protocol ID
- HUM00064483
- Status last verified
- Jan 2016
- First submitted
- 7 Mar 2014
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02088229
- Acronym / sponsor ID
- HUM00064483
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals undergoing treatment for diabetic macular edema at the University of Michigan W.K. Kellogg Eye Center.
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dark adaptation (AdaptRx)
Time frame: 12 Months
Rod intercept (minutes)
1 secondary outcome
Optical coherence tomography
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
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A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant Comer, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dark adaptation (AdaptRx) (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.