Macular Edema Clinical Trial
Official title:
An Open-label, Dose Escalating Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion
The purpose of the study is to evaluate the safety and tolerability of a single administration of FOV2302 (ecallantide) in patients with macular edema associated with central retinal vein occlusion.
Occlusive retinal vascular disease is not uncommon. Central retinal vein occlusion (CRVO) is
the second most common vision-impairing vascular disorder of the retina following diabetic
retinopathy. Severe visual loss from CRVO is caused by a combination of retinal edema and
neovascular proliferation and ischemia. Vascular endothelial factors as they stimulate
angiogenesis and increase vascular permeability, are majors pathogenic factors in CRVO.
Counteracting these neovascular effects provide significant therapeutic benefit to subjects
suffering from this disorder. Macular edema in this condition results from a conjunction of
several, as yet, partially unknown factors.
Macular edema may occur in diseases causing cumulative injury over many years, such as
diabetic retinopathy, or as a result of more acute events, such as branch retinal vein
occlusion (BRVO) or central retinal vein occlusion (CRVO).
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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