The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration
Condition: Choroidal Neo-Vascular Age-onset Macular Degeneration; Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Everolimus; Ranibizumab
Intervention description: 5 mg oral tablet; 0.5 mg administered by intravitreal injection
Intervention MeSH terms: Everolimus; Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; macular degeneration; Everolimus; Lucentis; Ranibizumab; Choroidal Neo-Vascular (CNV) age-onset macular degeneration; Age-related Macular Degeneration (AMD)

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