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CompletedNCT01535495Updated Mar 31, 2017

Propranolol for Diabetic Retinopathy

A Phase 1 interventional study of Propranolol in Proliferative Diabetic Retinopathy, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-31.

Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Proliferative Diabetic Retinopathy

Keywords

  • beta-antagonist
  • propranolol
  • diabetic retinopathy
  • diabetes
  • angiogenesis
  • neovascularization
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In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 9 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Complete laser

    Patients who have had complete panretinal photocoagulation laser treatment and active retinal neovascularization

    Drug: Propranolol

  • Experimental
    Laser naive

    Patients who have not had panretinal photocoagulation laser treatment and active retinal neovascularization without so called "high-risk" characteristics

    Drug: Propranolol

Interventions

  • DrugPropranolol

    Propranolol XL 120mg by mouth once daily

    Also known as: Both groups receive the same intervention

06

What researchers measure

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

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Study locations

1 site
  • University of Wisconsin - Madison
    Madison, Wisconsin 53705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01535495
Lead sponsor
University of Wisconsin, Madison
Responsible party
Sponsor
First posted
Feb 17, 2012
Start date
Feb 2012
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Mar 31, 2017

Study contacts

Michael S Ip, MD
principal investigator · UW Madison

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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