Propranolol for Diabetic Retinopathy
Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Proliferative Diabetic Retinopathy
Intervention: Propranolol (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s): Michael S Ip, MD, Principal Investigator, Affiliation: UW Madison
Overall contact: Andrew M Hendrick, MD, Phone: 608-263-7171, Email: ahendrick@ophth.wisc.edu
Summary
This study is investigating if the oral beta antagonist propranolol can induce regression of
retinal neovascularization associated with proliferative diabetic retinopathy.
Clinical Details
Official title: Propranolol for Diabetic Retinopathy
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area of retinal neovascularization on fundus photography
Secondary outcome: Retinopathy level in contralateral eyeOptical coherence tomography macular thickness of treated and fellow eye Amount of fluorescein leakage on angiography Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Andrew M Hendrick, MD, Phone: 608-263-7171, Email: ahendrick@ophth.wisc.edu
University of Wisconsin - Madison, Madison, Wisconsin 53705, United States; Recruiting Andrew M Hendrick, MD
Additional Information
Starting date: February 2012
Last updated: June 22, 2015
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