Uveitic Cystoid Macular Edema Clinical Trial
Official title:
Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
Uveitic Cystoid Macular Edema (CME) is a major cause of visual loss associated with uveitis.
Systemic and/or local corticosteroid therapy and systemic immunosuppression with
steroid-sparing agents such as cyclosporine, methotrexate, azathioprine, or others,
effectively treats uveitis and associated CME in many patients. However, in many cases, CME
persists in spite of adequate suppression of uveitis. No consensus exists on how best to
treat such cases. The further addition of immunosuppressive agents appears to have little
effect on this form of CME. Oral corticosteroids are useful, but high dosage and prolonged
use can be associated with serious side-effects. Periocular and intravitreal corticosteroid
injections are associated with well-known, significant side effects such as glaucoma and
cataract formation.
Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of
vascular integrity in the eye and known to be induced by inflammatory cytokines, such as
interleukin interleukin (IL)-1β and IL-6, which are elevated intraocularly in uveitis. In
addition, it has been demonstrated that aqueous VEGF concentrations are statistically
significantly higher in those uveitis patients with CME than those without CME. Inhibition
of inappropriate VEGF activity is a potential approach to treatment of CME in uveitis given
our current knowledge of the pathophysiology of this condition and also because of the
clinical need for additional treatment options for these patients. Ranibizumab, a
recombinant, humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes
all active forms of VEGF-A, would target this pathway and may be useful in cases of
persistent CME in uveitis patients.
The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and
effective in leading to regression of macular edema due to chronic non-infectious uveitis in
patients with well-controlled uveitis.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment