Propranolol for Diabetic Retinopathy

Phase 1

Completed

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Drug: Propranolol

• Registration Number: NCT01535495
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete laser	Propranolol	Patients who have had complete panretinal photocoagulation laser treatment and active retinal neovascularization
Laser naive	Propranolol	Patients who have not had panretinal photocoagulation laser treatment and active retinal neovascularization without so called "high-risk" characteristics

Primary Outcome Measures

Name	Time	Method
Area of retinal neovascularization on fundus photography	12 weeks

Secondary Outcome Measures

Name	Time	Method
Retinopathy level in contralateral eye	12 weeks
Optical coherence tomography macular thickness of treated and fellow eye	12 weeks
Amount of fluorescein leakage on angiography	12 weeks
Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye	12 weeks

Trial Locations

Locations (1)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States