- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00857259
The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration
July 22, 2011 updated by: Novartis Pharmaceuticals
A Randomized, Double-masked, Parallel Group Study to Assess the Efficacy of Oral Everolimus, Either Alone or Added to Lucentis, in Patients With Neovascular Age-related Macular Degeneration
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 Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bristol, United Kingdom
- Novartis Investigative Site
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Frimley, United Kingdom
- Novartis Investigative Site
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Liverpool, United Kingdom
- Novartis Investigative Site
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London, United Kingdom
- Novartis Investigative Site
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Oxford, United Kingdom
- Novartis Investigative Site
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Portsmouth, United Kingdom
- Novartis Investigative Site
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Southampton, United Kingdom
- Novartis Investigative Site
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Wolverhampton, United Kingdom
- Novartis Investigator Site
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California
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Beverley Hills, California, United States, 90211
- Retina-Vitreous Associates Medical Group
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Sacramento, California, United States
- Retinal Consultants Medical Group, Inc.
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Colorado
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Denver, Colorado, United States, 80210
- Porter Adventist Hospital, Diagnostic Eye Laboratory
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Missouri
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Independence, Missouri, United States, 64055
- Discover Vision Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Everolimus 5 mg
5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28
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5 mg oral tablet
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Active Comparator: Ranibizumab 0.5 mg
Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
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0.5 mg administered by intravitreal injection
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Active Comparator: Oral Everolimus (5mg) and Ranibizumab (0.5mg)
Everolimus orally 5 mg once daily plus Ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
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5 mg oral tablet
0.5 mg administered by intravitreal injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)
Time Frame: Baseline and 4 weeks
|
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.
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Baseline and 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus
Time Frame: Baseline and week 4
|
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.
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Baseline and week 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
March 4, 2009
First Submitted That Met QC Criteria
March 5, 2009
First Posted (Estimate)
March 6, 2009
Study Record Updates
Last Update Posted (Estimate)
August 19, 2011
Last Update Submitted That Met QC Criteria
July 22, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRAD001A2203
- EudraCT number: 2008-003550-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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