NCT01535495

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

3.8 years

First QC Date

February 14, 2012

Last Update Submit

March 29, 2017

Conditions

Proliferative Diabetic Retinopathy

Keywords

beta-antagonistpropranololdiabetic retinopathydiabetesangiogenesisneovascularization

Outcome Measures

Primary Outcomes (1)

  • Area of retinal neovascularization on fundus photography

    12 weeks

Secondary Outcomes (4)

  • Retinopathy level in contralateral eye

    12 weeks

  • Optical coherence tomography macular thickness of treated and fellow eye

    12 weeks

  • Amount of fluorescein leakage on angiography

    12 weeks

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

    12 weeks

Study Arms (2)

Complete laser

EXPERIMENTAL

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

Drug: Propranolol

Laser naive

EXPERIMENTAL

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

Drug: Propranolol

Interventions

PropranololDRUG

Propranolol XL 120mg by mouth once daily

Also known as: Both groups receive the same intervention
Complete laserLaser naive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes MellitusNeovascularization, Pathologic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Michael S Ip, MD

    UW Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 17, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

US(1)