Diabetic RetinopathyPhase 1NCT02099981
Restoration of Retinal Vascular Responses in Type 1 Diabetic Patients
A Phase 1 study testing Aminoguanidine in people with Diabetic Retinopathy, run by University of Minnesota at 1 site in United States.
Trial summary
Diabetic retinopathy is the leading cause of blindness in the developed world. The causes of the disease are poorly understood. One of the earliest changes that occur in the retinas of diabetic patients, well before overt retinopathy is observed, is a reduction in light-evoked increases in blood flow in retinal… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Aminoguanidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 1 diabetes between 18 and 65 years of age
- Diabetes duration between 5 to 20 years.
- Normal report or minor findings on a dilated eye exam
- Healthy subjects on no medications
Who cannot join
- Current diagnosis or history of:
- hypertension
- dyslipidemia
- epilepsy
- glaucoma or other ocular disease
- renal insufficiency/failure (creatinine >1.5 mg/dL)
- pregnancy or breastfeeding.
- smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
About this study
Diabetic retinopathy is the leading cause of blindness in the developed world. The causes of the disease are poorly understood. One of the earliest changes that occur in the retinas of diabetic patients, well before overt retinopathy is observed, is a reduction in light-evoked increases in blood flow in retinal vessels. The loss of this vascular response may lead to retinal hypoxia and it has been suggested that hypoxia could be a principal cause of diabetic retinopathy.
The long-term goals of this project are to determine whether decreased blood flow in diabetic patients and the resulting retinal hypoxia contributes to the development of diabetic retinopathy and whether restoration of normal blood flow in diabetic patients slows or prevents the development of retinopathy.
Read the detailed description
The immediate goal of the proposed project is to determine whether administration of aminoguanidine (AG) restores light--evoked vasodilations in the retinas of patients without advanced retinopathy. We will also determine whether AG improves contrast sensitivity in diabetic patients. The proposed experiments are as a first step in developing new therapies to prevent diabetic retinopathy.
Study participants will be asked to come to the University of Minnesota on three (3) occasions (the visits will last for up to 2, 5 and 3 hours respectively).
Visit 1. During the screening visit (first and shortest visit), consent will be obtained and baseline labs collected (Hemoglobin A1c and Creatinine). Demographic information (date of birth, gender, race), subjects characteristics (weight, height, blood pressure and pulse) and relevant medical history will be recorded.
Visit 2. Vessel dilation testing: Control and diabetic subjects will present to the Ophthalmology Research Unit at the University of Minnesota. Prior to the imaging examination, each subject will receive dilating eye drops (1% Tropicamide) to prevent accommodation of the pupil and brief eye exam will be performed. Measurement of resting vessel diameter and light--evoked vessel dilation will be made using the Imedos Systems "Dynamic Vessel Analyzer". Subjects will be instructed to look at a fixation spot and a 350 s sequence of fundus images will be acquired during baseline and stimulation period. After completion of the initial vasodilation measurements, both control and diabetic subjects will be given 150 mg AG orally and measurement of resting vessel diameter and light--evoked vasodilation will be repeated 90 minutes later.
Visit 3. Contrast sensitivity testing: Contrast sensitivity will be assessed in un-dilated control and diabetic subjects. Contrast sensitivity will be determined both before and after AG administration using a CSV-100 test chart (VectorVision) and will be measured at 3, 6, 12, and 18 cycles per degree.
- Conditions
- Diabetic Retinopathy
- Being tested
- Aminoguanidine
- Keywords
- Diabetes, Diabetic, Retinopathy, Ophthalmology, Eye, Eyes
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminoguanidineDrug
Also called AG
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Control subjects will receive AG. Receives: Drug: Aminoguanidine |
| Type 1 diabetes | Experimental | Type 1 diabetic subjects will receive AG. Receives: Drug: Aminoguanidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The vascular response to flicker
The vascular response will be defined as the ratio of the maximal vessel diameter observed during the stimulation period, compared to the mean diameter during the control period
Measured: 90 minutes
Secondary outcomes (1)
Contrast sensitivity
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Seaquist, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099981
- Sponsor's protocol ID
- Protocol 22503
- Status last verified
- Jan 2018
- First submitted
- 26 Mar 2014
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Retinal Vascular Responses in Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02099981
- Acronym / sponsor ID
- Protocol 22503
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetes, Diabetic, Retinopathy, Ophthalmology, Eye, Eyes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 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.
Diabetic retinopathy is the leading cause of blindness in the developed world. The causes of the disease are poorly understood. One of the earliest changes that occur in the retinas of diabetic patients, well before overt retinopathy is observed, is a reduction in light-evoked increases in blood flow in retinal vessels. The loss of this vascular response may lead to retinal hypoxia and it has been suggested that hypoxia could be a principal cause of diabetic retinopathy.
The long-term goals of this project are to determine whether decreased blood flow in diabetic patients and the resulting retinal hypoxia contributes to the development of diabetic retinopathy and whether restoration of normal blood flow in diabetic patients slows or prevents the development of retinopathy.
Detailed description
The immediate goal of the proposed project is to determine whether administration of aminoguanidine (AG) restores light--evoked vasodilations in the retinas of patients without advanced retinopathy. We will also determine whether AG improves contrast sensitivity in diabetic patients. The proposed experiments are as a first step in developing new therapies to prevent diabetic retinopathy.
Study participants will be asked to come to the University of Minnesota on three (3) occasions (the visits will last for up to 2, 5 and 3 hours respectively).
Visit 1. During the screening visit (first and shortest visit), consent will be obtained and baseline labs collected (Hemoglobin A1c and Creatinine). Demographic information (date of birth, gender, race), subjects characteristics (weight, height, blood pressure and pulse) and relevant medical history will be recorded.
Visit 2. Vessel dilation testing: Control and diabetic subjects will present to the Ophthalmology Research Unit at the University of Minnesota. Prior to the imaging examination, each subject will receive dilating eye drops (1% Tropicamide) to prevent accommodation of the pupil and brief eye exam will be performed. Measurement of resting vessel diameter and light--evoked vessel dilation will be made using the Imedos Systems "Dynamic Vessel Analyzer". Subjects will be instructed to look at a fixation spot and a 350 s sequence of fundus images will be acquired during baseline and stimulation period. After completion of the initial vasodilation measurements, both control and diabetic subjects will be given 150 mg AG orally and measurement of resting vessel diameter and light--evoked vasodilation will be repeated 90 minutes later.
Visit 3. Contrast sensitivity testing: Contrast sensitivity will be assessed in un-dilated control and diabetic subjects. Contrast sensitivity will be determined both before and after AG administration using a CSV-100 test chart (VectorVision) and will be measured at 3, 6, 12, and 18 cycles per degree.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Drug: AminoguanidineControl subjects will receive AG. |
| Type 1 diabetes | Experimental | Drug: AminoguanidineType 1 diabetic subjects will receive AG. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes between 18 and 65 years of age
- Diabetes duration between 5 to 20 years.
- Normal report or minor findings on a dilated eye exam
- Healthy subjects on no medications
Key exclusion criteria (8 listed)
- hypertension
- dyslipidemia
- epilepsy
- glaucoma or other ocular disease
- renal insufficiency/failure (creatinine >1.5 mg/dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AminoguanidineAlso: AG | Drug | Control Group, Type 1 diabetes |
Primary outcome
The vascular response to flicker
Time frame: 90 minutes
The vascular response will be defined as the ratio of the maximal vessel diameter observed during the stimulation period, compared to the mean diameter during the control period
1 secondary outcome
Contrast sensitivity
Time frame: 90 minutes
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 18 Jan 2018.
Related trials for Diabetic Retinopathy
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
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.
Elizabeth Seaquist, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aminoguanidine in people with Diabetic Retinopathy, run by University of Minnesota 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 8 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 18 Jan 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The vascular response to flicker (time frame: 90 minutes). 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 18 Jan 2018.