Proliferative Diabetic RetinopathyPhase 1NCT01535495
Propranolol for Diabetic Retinopathy
A Phase 1 study testing Propranolol in people with Proliferative Diabetic Retinopathy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years
- Eyes with proliferative diabetic retinopathy and neovascularization
- Eyes with a history of panretinal photocoagulation treatment and persistent neovascularization deemed by the investigator to be a potential threat to visual acuity either by causing a vitreous hemorrhage or tractional retinal detachment. (Group 1 - maximum 5 eyes enrolled with these characteristics)
- Eyes without a history of panretinal photocoagulation treatment, but that do not have high-risk proliferative diabetic retinopathy characteristics (i.e. these are eyes that have early proliferative diabetic retinopathy that are not yet at a high-risk for vitreous hemorrhage and tractional retinal detachment such that panretinal photocoagulation laser may be deferred). (Group 2 - maximum 5 eyes enrolled with these characteristics)
Who cannot join
- Either panretinal photocoagulation laser or focal/grid laser into study eye within 3 months of study enrollment
- Anti-Vascular endothelial growth factor injection into study eye within 3 months of study enrollment
- Contraindications to beta-blockers such as: allergy, previous intolerance, abnormally slow heart rates, asthma or chronic obstructive pulmonary disease, use of medications that have an effect on certain drug metabolic pathways that may cause interactions.
- Known coronary arterial disease or left ventricular dysfunction, or known peripheral vascular disease
- Resting heart rate <60 or systolic blood pressure <90 and/or diastolic blood pressure <50
- Pregnancy
Show all 11Show fewer
- All patients will either be post-menopausal, have adequate birth control and, if of childbearing age, will have a urinary pregnancy test performed
- Allergy to fluorescein dye
- Media opacity obscuring adequate determination of neovascularization including dense cataract or dense vitreous hemorrhage
- Patient is already taking an oral beta-blocker
- Vulnerable populations such as prisoners and minors will also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
About this study
This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.
Read the detailed description
Oral propranolol 120mg daily will be given to 10 patients with proliferative diabetic retinopathy over a 12 week period to evaluate the effect on retinal neovascularization.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Propranolol
- Keywords
- beta-antagonist, propranolol, diabetic retinopathy, diabetes, angiogenesis, neovascularization
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called Both groups receive the same intervention
Propranolol XL 120mg by mouth once daily
| Study group | Role | What they receive |
|---|---|---|
| Complete laser | Experimental | Patients who have had complete panretinal photocoagulation laser treatment and active retinal neovascularization Receives: Drug: Propranolol |
| Laser naive | Experimental | Patients who have not had panretinal photocoagulation laser treatment and active retinal neovascularization without so called "high-risk" characteristics Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of retinal neovascularization on fundus photography
Measured: 12 weeks
Secondary outcomes (4)
Retinopathy level in contralateral eye
Measured: 12 weeks
Optical coherence tomography macular thickness of treated and fellow eye
Measured: 12 weeks
Amount of fluorescein leakage on angiography
Measured: 12 weeks
Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S Ip, MD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535495
- Sponsor's protocol ID
- UW 2011-0475
- Status last verified
- Mar 2017
- First submitted
- 14 Feb 2012
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propranolol for Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01535495
- Acronym / sponsor ID
- UW 2011-0475
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- beta-antagonist, propranolol, diabetic retinopathy, diabetes, angiogenesis, neovascularization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Feb 2012 (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 study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.
Detailed description
Oral propranolol 120mg daily will be given to 10 patients with proliferative diabetic retinopathy over a 12 week period to evaluate the effect on retinal neovascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete laser | Experimental | Drug: PropranololPatients who have had complete panretinal photocoagulation laser treatment and active retinal neovascularization |
| Laser naive | Experimental | Drug: PropranololPatients who have not had panretinal photocoagulation laser treatment and active retinal neovascularization without so called "high-risk" characteristics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >=18 years
- Eyes with proliferative diabetic retinopathy and neovascularization
- Eyes with a history of panretinal photocoagulation treatment and persistent neovascularization deemed by the investigator to be a potential threat to visual acuity either by causing a vitreous hemorrhage or tractional retinal detachment. (Group 1 - maximum 5 eyes enrolled with these characteristics)
- Eyes without a history of panretinal photocoagulation treatment, but that do not have high-risk proliferative diabetic retinopathy characteristics (i.e. these are eyes that have early proliferative diabetic retinopathy that are not yet at a high-risk for vitreous hemorrhage and tractional retinal detachment such that panretinal photocoagulation laser may be deferred). (Group 2 - maximum 5 eyes enrolled with these characteristics)
Key exclusion criteria (11 listed)
- Either panretinal photocoagulation laser or focal/grid laser into study eye within 3 months of study enrollment
- Anti-Vascular endothelial growth factor injection into study eye within 3 months of study enrollment
- Contraindications to beta-blockers such as: allergy, previous intolerance, abnormally slow heart rates, asthma or chronic obstructive pulmonary disease, use of medications that have an effect on certain drug metabolic pathways that may cause interactions.
- Known coronary arterial disease or left ventricular dysfunction, or known peripheral vascular disease
- Resting heart rate <60 or systolic blood pressure <90 and/or diastolic blood pressure <50
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 |
|---|---|---|
| PropranololAlso: Both groups receive the same interventionPropranolol XL 120mg by mouth once daily | Drug | Complete laser, Laser naive |
Primary outcome
Area of retinal neovascularization on fundus photography
Time frame: 12 weeks
4 secondary outcomes
Retinopathy level in contralateral eye
Time frame: 12 weeks
Optical coherence tomography macular thickness of treated and fellow eye
Time frame: 12 weeks
Amount of fluorescein leakage on angiography
Time frame: 12 weeks
Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye
Time frame: 12 weeks
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 31 Mar 2017.
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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.
Michael S Ip, MD principal investigator
UW Madison
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 Propranolol in people with Proliferative Diabetic Retinopathy, run by University of Wisconsin, Madison 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 11 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 31 Mar 2017. 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?
Area of retinal neovascularization on fundus photography (time frame: 12 weeks). 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 31 Mar 2017.