Ischemia Clinical Trial
Official title:
A Phase I Open Label Study of the Safety, Tolerability and Efficacy of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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