Propranolol for Diabetic Retinopathy

University of Wisconsin (UW)

Status and phase: Completed; Phase 1

Conditions: Proliferative Diabetic Retinopathy

Treatments: Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01535495

UW 2011-0475

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Complete laser

Experimental group

Description:

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

Treatment:

Drug: Propranolol

Laser naive

Experimental group

Description:

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

Treatment:

Drug: Propranolol