Abstract
Purpose: :
The RAVE (Rubeosis Anti–VEGF) study is an ongoing 1–year, FDA Phase I open label clinical trial designed to test the safety and efficacy of nine monthly intravitreal injections of 0.5 mg ranibizumab (Lucentis). The primary endpoint in the study is the need for pan–retinal photocoagulation in the management of ischemic central retinal vein occlusion. Entry criteria include poor visual acuity (best corrected ETDRS refraction 0.9 log unit RAPD), loss of 12e isopter on Goldman visual field, and reduction of B–wave on ERG (equivalent to 60% of the A–wave). Secondary endpoints in the RAVE trial are changes in visual acuity and changes on OCT–measured central macular thickness. Macular edema in central retinal vein occlusion is thought to be mediated by both venous stasis (increased retinal venous pressure) and ischemia–mediated VEGF production.
Methods: :
The first patient enrolled in the RAVE study met all entry criteria and was injected with 0.5 mg Ranibizumab as per the FDA protocol. OCT and visual acuity with ETDRS refraction were performed prior to and immediately following treatment.
Results: :
At baseline, the first RAVE patient had marked macular thickening with a central OCT thickness of 573 +/–100 microns. Macular thickening decreased to 233+/–45 microns at 3 weeks after the intravitreal injection of 0.5mg of ranibizumab (a potent, specific pan–VEGF blocking antibody fragment).
Conclusions: :
This case suggests that macular edema in human CRVO may be modified by the intravitreal injection of a potent VEGF inhibiting agent (0.5 mg ranibizumab). The resolution of macular edema in this case may imply the macular edema that can be present in ischemic CRVO is mediated in large part by VEGF and that venous stasis (increased venous pressure) effects appear to be minimal. Further study of the use of a potent VEGF inhibitor such as intravitreal ranibizumab in patients with ischemic CRVO is warranted.
Keywords: retina • macula/fovea • imaging/image analysis: clinical