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

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00857259
First received: March 4, 2009
Last updated: July 22, 2011
Last verified: July 2011
History of Changes

March 4, 2009
July 22, 2011
February 2009
July 2010   (final data collection date for primary outcome measure)
Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
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.
Reduction of central retinal thickness, as measured by optical coherence tomography Measure: Optical Coherence Tomography ( OCT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00857259 on ClinicalTrials.gov Archive Site
Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
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.
Increase in visual acuity Measure: ETDRS Visual acuity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration
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)
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Choroidal Neo-Vascular Age-onset Macular Degeneration
  • Age-related Macular Degeneration
  • Drug: Everolimus
    5 mg oral tablet
  • Drug: Ranibizumab
    0.5 mg administered by intravitreal injection
  • Experimental: Everolimus 5 mg
    5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28
    Intervention: Drug: Everolimus
  • Active Comparator: Ranibizumab 0.5 mg
    Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
    Intervention: Drug: Ranibizumab
  • 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)
    Interventions:
    • Drug: Everolimus
    • Drug: Ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00857259
CRAD001A2203, EudraCT number: 2008-003550-15
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP