Propranolol for Diabetic Retinopathy

March 29, 2017 updated by: University of Wisconsin, Madison
This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Complete laser
Patients who have had complete panretinal photocoagulation laser treatment and active retinal neovascularization
Drug: Propranolol
Propranolol XL 120mg by mouth once daily
Other Names:
  • Both groups receive the same intervention
Experimental: Laser naive
Patients who have not had panretinal photocoagulation laser treatment and active retinal neovascularization without so called "high-risk" characteristics
Drug: Propranolol
Propranolol XL 120mg by mouth once daily
Other Names:
  • Both groups receive the same intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area of retinal neovascularization on fundus photography
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Michael S Ip, MD, UW Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 14, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimate)

February 17, 2012

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 2011-0475

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Proliferative Diabetic Retinopathy

Clinical Trials on Propranolol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe