Clinical trial NCT01535495: Propranolol for Diabetic Retinopathy
Official title: Propranolol for Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Proliferative Diabetic Retinopathy
Keywords: beta-antagonist
propranolol
diabetic retinopathy
diabetes
angiogenesis
neovascularization
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Area of retinal neovascularization on fundus photography
timeFrame: 12 weeks
Secondary outcomes:
measure: Retinopathy level in contralateral eye
timeFrame: 12 weeks
measure: Optical coherence tomography macular thickness of treated and fellow eye
timeFrame: 12 weeks
measure: Amount of fluorescein leakage on angiography
timeFrame: 12 weeks
measure: Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: UW Madison
name: Michael S Ip, MD
role: PRINCIPAL_INVESTIGATOR
References: