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OpenTrials
Completed

NCT Number: NCT01535495

Propranolol for Diabetic Retinopathy

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol

Drug

Propranolol XL 120mg by mouth once daily

Other names: Both groups receive the same intervention

Primary outcomes

  1. Area of retinal neovascularization on fundus photography

    Time frame: 12 weeks

Secondary outcomes

  1. Retinopathy level in contralateral eye

    Time frame: 12 weeks

  2. Optical coherence tomography macular thickness of treated and fellow eye

    Time frame: 12 weeks

  3. Amount of fluorescein leakage on angiography

    Time frame: 12 weeks

  4. Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2012
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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