Overview

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

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Everolimus
Ranibizumab
Sirolimus
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