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Clinical Trial Summary

Significant difference in the parameter settings of early optical coherence tomography (OCT spectal domain) in patients with subfoveal neovascular membrane realacionada age after treatment with a single intravitreal injection of Lucentis.


Clinical Trial Description

Assessment in early changes in the parameters of optical coherence tomography (OCT spectral domain) in patients with subfoveal neovascularization secondary to age-related degeneration after treatment with a single intravitreal injection of Lucentis.

Age-related macular degeneration (AMD) leading cause of blindness over 50 years in developed Western countries. Its prevalence increases with age affecting about 8.5 to 27.9% of the population over 75 years. Its incidence has increased 30-40% in recent decades, in spite of eye diseases such as cataracts and glaucoma, which reach the same population group, have shown apparently reduced their records.

Although approximately 80% of patients with AMD have the neovascular form does not, the neovascular form is responsible for almost 90% of severe visual loss resulting from AMD. It creates great socioeconomic impact, becoming a public health problem.

Quantitative analysis of OCT has shown increasing clinical importance with the development of anti-VEGF therapy to evaluate the outcome of the treatment of neovascular AMD.

Relatively few studies in AMD has been proposed to examine the correlation between the morphological parameters of the OCT and BCVA in a systematic way.

It is important to assess the impact that different OCT parameters have on visual acuity as early as 7 days after intravitreal injection of ranibizumab in patients with AMD to define which of these parameters correlate better with the AV and prognosis. It is also unknown which patients' perception of the effectiveness of treatment in early stage. For this evaluation, we apply the visual function questionnaire (VFQ - 25) 1 and 7 days after treatment. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01669447
Study type Interventional
Source University of Campinas, Brazil
Contact OSIAS SOUZA, PI
Phone +55(19)97732770
Email osiasfs@uol.com.br
Status Not yet recruiting
Phase Phase 4
Start date September 2012
Completion date December 2012