Overview
Propranolol for Diabetic Retinopathy
Status:
Completed
Completed
Trial end date:
2015-12-01
2015-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Wisconsin, MadisonTreatments:
Propranolol
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