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