Clinical Trial: Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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)

Brief 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, ba

Detailed Summary:
Sponsor: Manhattan Eye, Ear & Throat Hospital

Current Primary Outcome: Safety and tolerability of intravitreal injections of ranibizumab in the treatment of non-AMD variants and other CNV related conditions [ Time Frame: 24 months ]

Original Primary Outcome: Safety and tolerability of intravitreal injections of Ranibizumab in the treatment of non-AMD variants and other CNV related conditions. [ Time Frame: 12 months ]

Current Secondary Outcome:

  • Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline [ Time Frame: 24 months ]
  • Change in leakage area seen during fluorescein angiography at month 12 as compared with baseline [ Time Frame: 24 months ]
  • Number of additional injections required following the initial 3 injections [ Time Frame: 24 months ]


Original Secondary Outcome:

  • Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline [ Time Frame: 12 months ]
  • Change in leakage area seen during fluorescein angiography at month 12 as compared with baseline • Number of additional injections required following the initial 3 injections. [ Time Frame: 12 months ]
  • Number of additional injections required following the initial 3 injections. [ Time Frame: 12 months ]


Information By: Manhattan Eye, Ear & Throat Hospital

Dates:
Date Received: May 4, 2007
Date Started: May 2007
Date Completion:
Last Updated: October 24, 2012
Last Verified: October 2012