A Phase 1/2 interventional study of Panretinal Photocoagulation and Panretinal Photocoagulation and intravitreal injection of ranibizumab in Retinal Ischemia, sponsored by Southern New England Retina Associates. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-19.
Sponsored by Southern New England Retina Associates · Phase 1/2, Interventional, and Treatment
The object of the study is to compare treatment of iris/angle neovascularization with panretinal photocoagulation (laser) to treatment with panretinal photocoagulation and an anti-angiogenic drug: ranibizumab.
A.To obtain preliminary data on the safety and tolerability of ranibizumab (0.5 mg)in patients with new or progressive neovascularization of the iris or angle due to retinal ischemic diseases in addition to treatment with PRP using the incidence and severity of adverse events identified by subjenc reporting vital signs, and ocular examition.
B.To assess the proportion of patients who fail to experience regression of iris and angle neovascularization documented by the clinical examination, iris florescein angiography and gonioscopic evaluation.
2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.
This study's enrollment of 1 is below the median of 80 across 1,359 interventional studies indexed under Ischemia.
Browse Ischemia studies →This is the only study on the registry with Southern New England Retina Associates as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All subjects must meet the following criteria to be eligible for study entry:
Exclusion Criteria:
Panretinal Photocoagulation
Procedure: Panretinal Photocoagulation
Ranibizumab Supplementing Panretinal Laser Photocoagulation
Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab
Panretinal Photocoagulation treatment
Panretinal photocoagulation and ranibizumab
Also known as: laser and Lucentis
The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam.
Time frame: 1 to 12 months
The proportion of patients who fail to maintain regression of iris and angle neovascularization documented by the clinical examination iris fluorescein angiography and gonioscopic evaluation.
Time frame: 1 to 12 months
The mean change in best corrected visual acuity score
Time frame: 1 to 12 months
The percentage/number of patients that experience vision loss of 30 letters or less
Time frame: 1 to 12 months
The percentage number of patients that experience vision improvement of more than 15 letters
Time frame: 1 to 12 months
The percentage/number of patients whose vision progressed to no light perception
Time frame: 1 to 12 months
The mean change in macular thickness on OCT
Time frame: 1 to 12 months
The percentage/number of eyes that will require surgical intervention to maintain the intraocular pressure or useful vision
Time frame: 1 to 12 months
The percentage/ number of eyes that will require anti-glaucoma medications to control intraocular pressure
Time frame: 1 to 12 months
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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