Clinical trial NCT00857259: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus
timeFrame: Baseline and week 4
Other outcomes:
Locations:
city: Beverley Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: Denver
country: United States
facility: Porter Adventist Hospital, Diagnostic Eye Laboratory
state: Colorado
city: Independence
country: United States
facility: Discover Vision Center
state: Missouri
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Frimley
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
city: Wolverhampton
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: