The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration (AMD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
5 mg oral tablet
0.5 mg administered by intravitreal injection
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States
Porter Adventist Hospital, Diagnostic Eye Laboratory
Denver, Colorado, United States
Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)
Central retinal thickness was assessed by Optical coherence tomography (OCT). The primary thickness endpoint was the mean thickness of the foveal field of the macula map produced by the analysis of the sequence of six radial scans. Foveal field thickness was the average thickness of a circular field with a diameter of 1 mm. OCT images were analyzed by a central reading center.
Time frame: Baseline and 4 weeks
Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus
Best corrected visual acuity (BCVA) was assessed on both eyes. BCVA measurements were taken in sitting position using Early Treatment Diabetic Retinopathy Study (ETDRs)-like visual acuity testing charts at an initial testing distance specific to test charts. BCVA is measured from the number of letters the patient can read on the eye chart.
Time frame: Baseline and week 4
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Discover Vision Center
Independence, Missouri, United States
Novartis Investigative Site
Bristol, United Kingdom
Novartis Investigative Site
Frimley, United Kingdom
Novartis Investigative Site
Liverpool, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Oxford, United Kingdom
Novartis Investigative site
Portsmouth, United Kingdom
...and 2 more locations