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The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5 or 2.0 mg of ranibizumab in patients with macular edema due to retinal vein occlusion.
The secondary objectives are to assess the bioactivity of 0.5 or 2.0 mg of ranibizumab in patients with macular edemas due to retinal vein occlusion by measuring the mean change from baseline in several parameters of visual function and retinal thickness at weeks 24 and 48. In addition, aqueous levels of cytokines and ranibizumab will be measured to assess for biomarkers of disease activity and response and to perform a pharmacodynamic analysis by correlating aqueous levels of ranibizumab with the above outcome measures. At week 24, patients will be re-randomized to receive laser photocoagulation to areas of capillary nonperfusion outside the fovea to assess the safety and tolerability of combination treatment with laser and ranibizumab.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Retinal Vein Occlusion
Ranibizumab .5mg, Ranibizumab .5mg with laser, Ranibizumab 2.0 mg, Ranibizumab 2.o dose with laser
Wilmer Eye Institute at Johns Hopkins University
Johns Hopkins University
Published on BioPortfolio: 2010-07-15T17:00:00-0400
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A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Techniques using laser energy in combination with a balloon catheter to perform angioplasty. These procedures can take several forms including: 1, laser fiber delivering the energy while the inflated balloon centers the fiber and occludes the blood flow; 2, balloon angioplasty immediately following laser angioplasty; or 3, laser energy transmitted through angioplasty balloons that contain an internal fiber.
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