Propranolol for Diabetic Retinopathy

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

Detailed Description
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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.

Official Title
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Propranolol for Diabetic Retinopathy

Conditions
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Proliferative Diabetic Retinopathy

Intervention / Treatment
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* Drug: Propranolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complete laser<br>Patients who have had complete panretinal photocoagulation laser treatment and active retinal neovascularization | Drug: Propranolol<br>* Propranolol XL 120mg by mouth once daily<br>* Other names: Both groups receive the same intervention;|
| Experimental: Laser naive<br>Patients who have not had panretinal photocoagulation laser treatment and active retinal neovascularization without so called high-risk characteristics | Drug: Propranolol<br>* Propranolol XL 120mg by mouth once daily<br>* Other names: Both groups receive the same intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of retinal neovascularization on fundus photography |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta-antagonist, propranolol, diabetic retinopathy, diabetes, angiogenesis, neovascularization