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

Age-related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00857259
• Other study ID #: CRAD001A2203
• Secondary ID: EudraCT number:
• Status: Terminated
• Phase: Phase 2
• First received: March 4, 2009
• Last updated: July 22, 2011
• Start date: February 2009

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Choroidal Neo-Vascular Age-onset Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Everolimus
5 mg oral tablet
• Ranibizumab
0.5 mg administered by intravitreal injection

Locations

Country	Name	City	State
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 States	Retina-Vitreous Associates Medical Group	Beverley Hills	California
United States	Porter Adventist Hospital, Diagnostic Eye Laboratory	Denver	Colorado
United States	Discover Vision Center	Independence	Missouri
United States	Retinal Consultants Medical Group, Inc.	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 4 weeks	No
Secondary	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.	Baseline and week 4	No