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

Primary Purpose

Choroidal Neo-Vascular Age-onset Macular Degeneration, Age-related Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Everolimus
Ranibizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neo-Vascular Age-onset Macular Degeneration focused on measuring AMD, macular degeneration, Everolimus, Lucentis, Ranibizumab, Choroidal Neo-Vascular (CNV) age-onset macular degeneration, Age-related Macular Degeneration (AMD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • Retinal Consultants Medical Group, Inc.
  • Porter Adventist Hospital, Diagnostic Eye Laboratory
  • Discover Vision Center
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Everolimus 5 mg

Ranibizumab 0.5 mg

Oral Everolimus (5mg) and Ranibizumab (0.5mg)

Arm Description

5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28

Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)

Everolimus orally 5 mg once daily plus Ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 4, 2009
Last Updated
July 22, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00857259
Brief Title
The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neo-Vascular Age-onset Macular Degeneration, Age-related Macular Degeneration
Keywords
AMD, macular degeneration, Everolimus, Lucentis, Ranibizumab, Choroidal Neo-Vascular (CNV) age-onset macular degeneration, Age-related Macular Degeneration (AMD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus 5 mg
Arm Type
Experimental
Arm Description
5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28
Arm Title
Ranibizumab 0.5 mg
Arm Type
Active Comparator
Arm Description
Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
Arm Title
Oral Everolimus (5mg) and Ranibizumab (0.5mg)
Arm Type
Active Comparator
Arm Description
Everolimus orally 5 mg once daily plus Ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
Intervention Type
Drug
Intervention Name(s)
Everolimus
Intervention Description
5 mg oral tablet
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
0.5 mg administered by intravitreal injection
Primary Outcome Measure Information:
Title
Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)
Description
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
Secondary Outcome Measure Information:
Title
Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverley Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retinal Consultants Medical Group, Inc.
City
Sacramento
State/Province
California
Country
United States
Facility Name
Porter Adventist Hospital, Diagnostic Eye Laboratory
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Discover Vision Center
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Novartis Investigative Site
City
Bristol
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Frimley
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Liverpool
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Oxford
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Portsmouth
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Southampton
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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