Propranolol for Diabetic Retinopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01535495
First received: February 14, 2012
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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 ]

Estimated Enrollment: 10
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: August 2012 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535495

Contacts
Contact: Andrew M Hendrick, MD 608-263-7171 ahendrick@ophth.wisc.edu
Contact: Barb Soderling 608-263-7171

Locations
United States, Wisconsin
University of Wisconsin - Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Andrew M Hendrick, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Michael S Ip, MD UW Madison
  More Information

No publications provided

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

Keywords provided by University of Wisconsin, Madison:
beta-antagonist
propranolol
diabetic retinopathy
diabetes
angiogenesis
neovascularization

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

ClinicalTrials.gov processed this record on October 19, 2014