Trial record 6 of 1005 for:    "Macular degeneration"

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
  Purpose

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)


Condition Intervention Phase
Choroidal Neo-Vascular Age-onset Macular Degeneration
Age-related Macular Degeneration
Drug: Everolimus
Drug: Ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 16
Study Start Date: February 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus 5 mg
5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28
Drug: Everolimus
5 mg oral tablet
Active Comparator: Ranibizumab 0.5 mg
Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
Drug: Ranibizumab
0.5 mg administered by intravitreal injection
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)
Drug: Everolimus
5 mg oral tablet
Drug: Ranibizumab
0.5 mg administered by intravitreal injection

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857259

Locations
United States, California
Retina-Vitreous Associates Medical Group
Beverley Hills, California, United States, 90211
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States
United States, Colorado
Porter Adventist Hospital, Diagnostic Eye Laboratory
Denver, Colorado, United States, 80210
United States, Missouri
Discover Vision Center
Independence, Missouri, United States, 64055
United Kingdom
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00857259     History of Changes
Other Study ID Numbers: CRAD001A2203, EudraCT number: 2008-003550-15
Study First Received: March 4, 2009
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Novartis:
AMD
macular degeneration
Everolimus
Lucentis
Ranibizumab
Choroidal Neo-Vascular (CNV) age-onset macular degeneration
Age-related Macular Degeneration (AMD)

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 23, 2014