Polypoidal Choroidal Vasculopathy Clinical Trial
Official title:
Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy With Intravitreal Injection of Lucentis (Ranibizumab Injection)
The purpose of this study is to evaluate the safety and tolerability of intravitreal
injections of ranibizumab in the treatment of AMD variants and other choroidal
neovascularization (CNV) related conditions (Coats' disease, idiopathic perifoveal
telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma
elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis) using the
incidence and severity of adverse events.
Limited forms of treatment are available that limit the loss of visual acuity. However, the
patients may not have any substantial improvement in acuity or function. Therefore there
remains a significant unmet need for therapeutic options managing the neovascularization and
its consequences.
Lucentis (ranibizumab) injection will be considered as an attempt to control the growth of
the abnormal vessels because of evidence suggesting that angiogenic factors, such as
vascular endothelial growth factor (VEGF), play a role in the pathogenesis of neovascular
non-AMD conditions.
The rationale for the study design is as follows:
A 0.5 mg dose of Lucentis (ranibizumab), a commercially available preparation that is Food
and Drug Administration (FDA) approved and labeled for intravitreal injection use for
neovascular (wet) age-related macular degeneration will be used.
In AMD variants and other CNV related conditions, vascular endothelial growth factor (VEGF)
plays a role in the pathogenesis as in neovascular AMD.
Intravitreal injection of ranibizumab delivers maximal concentration of the antibody
fragment to the vitreous cavity with minimal systemic exposure. The dosing schedule, based
on considerations of the half-life and the clinical response in patients with
neovascularization suggests that a 1-month interval is optimal.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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