Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy — FVF4140S  

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)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• BEST VITELLIFORM MACULAR DYSTROPHY, MULTIFOCAL (Disorder)
• Choroiditis
• Coats' Disease
• Idiopathic Retinal Telangiectasia
• Macular Degeneration
• Multi-focal Choroiditis
• Myopia, Degenerative
• Pathological Myopia
• Polypoidal Choroidal Vasculopathy
• Pseudoxanthoma Elasticum
• Retinal Angiomatous Proliferation
• Rubeosis Iridis
• Telangiectasis
• Vascular Diseases
• Vitelliform Macular Dystrophy
• Von Hippel Lindau Disease
• Von Hippel-Lindau Disease

• NCT number: NCT00470977
• Study type: Interventional
• Source: Manhattan Eye, Ear & Throat Hospital
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2007
• Completion date: December 2010