Propranolol for Diabetic Retinopathy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

Propranolol for Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535495
• Other study ID #: UW 2011-0475
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2012
• Last updated: March 29, 2017
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Propranolol
Propranolol XL 120mg by mouth once daily

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of retinal neovascularization on fundus photography		12 weeks
Secondary	Retinopathy level in contralateral eye		12 weeks
Secondary	Optical coherence tomography macular thickness of treated and fellow eye		12 weeks
Secondary	Amount of fluorescein leakage on angiography		12 weeks
Secondary	Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye		12 weeks