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Propranolol for Diabetic Retinopathy

Primary Purpose

Proliferative Diabetic Retinopathy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Propranolol

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring beta-antagonist, propranolol, diabetic retinopathy, diabetes, angiogenesis, neovascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Wisconsin - Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Complete laser

Laser naive

Arm Description

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

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

Outcomes

Primary Outcome Measures

Area of retinal neovascularization on fundus photography

Secondary Outcome Measures

Retinopathy level in contralateral eye

Optical coherence tomography macular thickness of treated and fellow eye

Amount of fluorescein leakage on angiography

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

Full Information

NCT ID

NCT01535495

First Posted

February 14, 2012

Last Updated

March 29, 2017

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT01535495

Brief Title

Propranolol for Diabetic Retinopathy

Official Title

Propranolol for Diabetic Retinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proliferative Diabetic Retinopathy

Keywords

beta-antagonist, propranolol, diabetic retinopathy, diabetes, angiogenesis, neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Complete laser

Arm Type

Experimental

Arm Description

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

Arm Title

Laser naive

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Propranolol

Other Intervention Name(s)

Both groups receive the same intervention

Intervention Description

Propranolol XL 120mg by mouth once daily

Primary Outcome Measure Information:

Title

Area of retinal neovascularization on fundus photography

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Retinopathy level in contralateral eye

Time Frame

12 weeks

Title

Optical coherence tomography macular thickness of treated and fellow eye

Time Frame

12 weeks

Title

Amount of fluorescein leakage on angiography

Time Frame

12 weeks

Title

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael S Ip, MD

Organizational Affiliation

UW Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin - Madison

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

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Propranolol for Diabetic Retinopathy

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