The RAVE (Rubeosis Anit-VEgf) trial, utilizes monthly intravitreal Ranibizumab (Lucentis) injections for 9 months to see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic central retinal vein occlusion.
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. Risks of intravitreal injections are well known and include endophthalmitis and retinal detachment. This risk should be less than 1% with proper injection technique and experienced retinal surgeons. As the incidence of neovascular glaucoma (with resultant loss of central and peripheral visual fields) is approximately 50% in ischemic CRVO, the small risk of intravitreal injection is warranted if the drug shows efficacy. In a small number of subjects in previous animal and human trials, intraocular pressure was acutely elevated when the drug volume was placed intravitreally. An eye with a compromised circulation (such as ischemic CRVO) may experience less perfusion if this occurred. Previous intravitreal studies of ranibizumab have not utilized anterior chamber paracentesis to compensate for the volume of intravitreal drug to be placed. This was reasonable because an eye with a normal retinal circulation can tolerate relatively high intraocular pressure for a limited time. This protocol for this study will include anterior chamber paracentesis prior to intravitreal injection to minimize this potential risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
500 microgram intravitreal injection for 8 months or 300 microgram intravitreal injection for 8 months
Vitreoretinal Consultants
Houston, Texas, United States
Preservation of 5Ve isopter Goldmann visual field versus baseline at 1 year
Time frame: 12 and 24 months
Estimate the % of subjects progressing to neovascular glaucoma requiring pan-retinal photocoagulation or glaucoma surgery after treatment with ranibizumab (comparing 0.3mg to 0.5mg doses)
Time frame: 12 and 24 mponths
Assess the systemic and local safety of 0.3mg and 0.5mg of ranibizumab in patients with ischemic CRVO
Time frame: 12 and 24 months
Assess improvement from baseline in Visual Acuity at 1 year
Time frame: 12 and 24 months
Assess the impact on retinal thickness and volume (as measured by OCT)
Time frame: 12 and 24 months
Assess the impact of ranibizumab (0.3mg and 0.5mg) on time to improvement in visual acuity
Time frame: 12 and 24 months
Asses the impact of ranibizumab (0.3mg and 0.5mg) on time to improvement in retinal thickness
Time frame: 12 and 24 months
Asses the impact of ranibizumab (0.3mg and 0.5mg) on percentage of patients developing 3 or more clock hours of rubeosis at 6 and 12 months and 24 months
Time frame: 6, 12, and 24 months
Assess the impact of ranibizumab (0.3mg and 0.5mg) on prevention of greater than 3 clock hours rubeosis (as measured by iris fluorescein angiography)
Time frame: 12 and 24 months
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Assess the impact of ranibizumab on the gain or decrease of area of visual field on 14e Goldman visual field area
Time frame: 12 and 24 months
Assess the impact of ranibizumab on b wave component of ERG
Time frame: 12 and 24 months
Aqueous VEGF levels
Time frame: 24 months