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Proliferative Diabetic Retinopathy | Propranolol for Diabetic Retinopathy

Proliferative Diabetic Retinopathy research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Proliferative Diabetic Retinopathy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PropranololPropranolol XL 120mg by mouth once daily

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: February 2012

Completed Date: December 2015

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Area of retinal neovascularization on fundus photography

Secondary Outcome: Retinopathy level in contralateral eye

Study sponsors, principal investigator, and references

Principal Investigator: Michael S Ip, MD

Lead Sponsor: University of Wisconsin, Madison

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01535495

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