Propranolol for Diabetic Retinopathy

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: February 14, 2012
Last updated: December 17, 2015
Last verified: December 2015
This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.

Condition Intervention
Proliferative Diabetic Retinopathy
Drug: Propranolol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Propranolol for Diabetic Retinopathy

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Area of retinal neovascularization on fundus photography [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retinopathy level in contralateral eye [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Optical coherence tomography macular thickness of treated and fellow eye [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Amount of fluorescein leakage on angiography [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: February 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Both groups receive the same intervention

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01535495

United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Michael S Ip, MD UW Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT01535495     History of Changes
Other Study ID Numbers: UW 2011-0475 
Study First Received: February 14, 2012
Last Updated: December 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
diabetic retinopathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Vascular Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents processed this record on April 27, 2016