Overview

Propranolol for Diabetic Retinopathy

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Wisconsin, Madison
Treatments:
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