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Propranolol for Diabetic Retinopathy

Information source: University of Wisconsin, Madison
Information obtained from ClinicalTrials.gov on February 07, 2013
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 eye

Optical 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: February 17, 2012

Page last updated: February 07, 2013

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