The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration

Stopped early · Phase 2

Conditions studied: Choroidal Neo-Vascular Age-onset Macular Degeneration, Age-related Macular Degeneration

In brief

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)

Key facts

Study ID

NCT00857259

Run by

Novartis Pharmaceuticals

People needed

16

Starts

2009-02-01

Last updated by the study team

2011-08-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with neovascular Age-Related Macular Degeneration (AMD)
• Best corrected visual acuity ( BCVA) of 20/40 or worse in study eye
• Patients with predominantly classic, minimally classic, or occult choroidal neovascularization in the macula of one eye (the study eye) who have had an inadequate response to VEGF inhibitors in the study eye. Inadequate response is defined as a gain of less than one line of visual acuity and persistent macular edema (central sub-fiel thickness ≥ 300 μm as measured by Optical Coherence Tomography (OCT) despite a minimum of 3 treatments with Lucentis or Avastin

You may not qualify if…

• Any concurrent ocular condition in the study eye that may result in substantial change in vision during the study
• Uncontrolled medical conditions such as cancer, angina, diabetes, viral or fungal infections, impaired lung function, history of stroke
• Patients who have macular edema in the study eye that, in the judgment of the investigator, is unlikely to respond to treatment. Examples of features that may guide the investigator's judgment about unresponsiveness are large regions of geographic atrophy, retinal angiomatous proliferation, or large regions of sub-retinal fibrosis. The presence of one of these features excludes a patient only if the investigator judges the study eye to have irreversible macular edema.
• active bacterial, fungal or viral infections at the time of enrollment, e.g. hepatitis B or C infection. Patients with risk factors for hepatitis B should be tested for hepatitis B viral load and serological markers at screening (a positive HBV-DNA, HBsAg). Patients with risk factors for hepatitis C should be tested using HCVRNA-PCR at screening. A clinical history of hepatitis B or hepatitis C will exclude the patient from the study.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• 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
• Novartis Investigative Site — Southampton, United Kingdom
• Novartis Investigator Site — Wolverhampton, United Kingdom

Full record on ClinicalTrials.gov

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