The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg in patients with ischemic CRVO who have been either previously treated with ranibizumab or treatment naïve.
The most devastating complication of ischemic CRVO is the development of anterior segment neovascularization and the resulting morbidity from neovascular glaucoma. This complication appears to be directly correlated with intraocular VEGF levels. Currently there is no proven treatment to decrease the formation of rubeosis. Current management of the disease consists of pan-retinal photocoagulation once significant anterior segment neovascularization becomes manifest. This treatment destroys peripheral retina (with peripheral retinal field) and presumably works by eventually lowering ocular VEGF levels which causes secondary regression of rubeosis. As ranibizumab blocks VEGF, this treatment when delivered intraocularly may prevent neo-vascular glaucoma while preserving peripheral visual fields in this patient population. A higher dose of ranibizumab may allow for both a longer duration of treatment effect and potentially more efficacy leading to better outcomes for patients that are somewhat treatment resistant and need continual therapy. Nonclinical and early clinical data indicate that higher doses of ranibizumab up to and including 2.0 mg are safe and tolerated by patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
Retina Consultants of Houston
Houston, Texas, United States
Mean Change in logMAR
Mean change from baseline in ETDRS NCVA.
Time frame: 12 months.
Incidence and Severity of Adverse Events (Ocular and Non-ocular).
Incidence and severity of adverse events (ocular and non-ocular) from baseline through 12 months will be evaluated.
Time frame: 12 months
Neovascularization Development
Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.
Time frame: 12 months
Mean Change in Central Foveal Volume
Mean change in Central Foveal Volume on High Resolution OCT
Time frame: 12 months
Changes, by Disc Areas, of Capillary Non-perfusion in the Periphery
Changes, by disc areas, of capillary non-perfusion in the periphery (evaluated by wide-field fluorescein angiography) at 3, 6, 9 and 12 months from baseline.
Time frame: 12 months
Goldman Visual Field Changes
Goldman Visual Field changes at 6 and 12 months from baseline
Time frame: 12 months
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