Propranolol for Diabetic Retinopathy
This study is currently recruiting participants.
Verified February 2012 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01535495
First received: February 14, 2012
Last updated: February 17, 2012
Last verified: February 2012
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Purpose
This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.
| Condition | Intervention |
|---|---|
|
Proliferative Diabetic Retinopathy |
Drug: Propranolol |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Propranolol for Diabetic Retinopathy |
Resource links provided by NLM:
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- Area of retinal neovascularization on fundus photography [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Retinopathy level in contralateral eye [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Optical coherence tomography macular thickness of treated and fellow eye [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Amount of fluorescein leakage on angiography [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Complete laser
Patients who have had complete panretinal photocoagulation laser treatment and active retinal neovascularization
|
Drug: Propranolol
Propranolol XL 120mg by mouth once daily
Other Name: Both groups receive the same intervention
|
|
Experimental: Laser naive
Patients who have not had panretinal photocoagulation laser treatment and active retinal neovascularization without so called "high-risk" characteristics
|
Drug: Propranolol
Propranolol XL 120mg by mouth once daily
Other Name: Both groups receive the same intervention
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535495
Contacts
| Contact: Andrew M Hendrick, MD | 608-263-7171 | ahendrick@ophth.wisc.edu |
| Contact: Barb Soderling | 608-263-7171 |
Locations
| United States, Wisconsin | |
| University of Wisconsin - Madison | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Andrew M Hendrick, MD | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Principal Investigator: | Michael S Ip, MD | UW Madison |
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01535495 History of Changes |
| Other Study ID Numbers: | UW 2011-0475 |
| Study First Received: | February 14, 2012 |
| Last Updated: | February 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Wisconsin, Madison:
|
beta-antagonist propranolol diabetic retinopathy |
diabetes angiogenesis neovascularization |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Propranolol Anti-Arrhythmia Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents |
ClinicalTrials.gov processed this record on May 22, 2013