Clinical Trial: Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy Measured Using The Optical Coherence Tomography (OCT) Scanning Laser Ophthalmoscope (SLO)

Brief Summary: The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular (wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF levels in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been shown to maintain or improve vision in wet AMD. Since the treatments do not halt the loss of visual acuity in wet AMD, it is important to accurately measure anatomic response to treatments thereby enhancing the ability to understand patterns of response and predict the necessity for continued therapy.

Detailed Summary:
Sponsor: The New York Eye & Ear Infirmary

Current Primary Outcome: Central retinal thickness [ Time Frame: 12 months ]

To measure the mean change in central retinal thickness as measured by OCT/ SLO and Stratus OCT from Baseline to Month 12.


Original Primary Outcome: Same as current

Current Secondary Outcome: change in central scotoma lesion size, density and distortion due to neovascularization [ Time Frame: 12 months ]

To measure the mean change in central scotoma lesion size and density as measured on OCT/ SLO microperimeter from Baseline to Month 12.

To measure the mean change in the scotoma size and distortion due to neovascularization as measured on the PHP from Baseline to Month 12.



Original Secondary Outcome: Same as current

Information By: The New York Eye & Ear Infirmary

Dates:
Date Received: December 4, 2010
Date Started: June 2007
Date Completion: December 2012
Last Updated: December 2, 2011
Last Verified: December 2011