Proliferative Diabetic Retinopathy
Conditions
Keywords
beta-antagonist, propranolol, diabetic retinopathy, diabetes, angiogenesis, neovascularization
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.
Interventions
DRUGPropranolol
Propranolol XL 120mg by mouth once daily
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area of retinal neovascularization on fundus photography | 12 weeks |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed