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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00857259
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Everolimus — DRUG
    5 mg oral tablet
  • Ranibizumab — DRUG
    0.5 mg administered by intravitreal injection

Study Details

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)

Key Dates

First listed
Mar 6, 2009
Start date
Feb 28, 2009
Status verified
Jul 2011
Primary completion
Jul 31, 2010

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Everolimus 5 mg
    5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28
  • Active Comparator: Ranibizumab 0.5 mg
    Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
  • 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)

Primary Outcome Measure

Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline and 4 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Retinal Consultants Medical Group, Inc.SacramentoCalifornia--
Porter Adventist Hospital, Diagnostic Eye LaboratoryDenverColorado80210-
Discover Vision CenterIndependenceMissouri64055-

Find similar trials in Beverly Hills, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CARetinal Consultants Medical Group, Inc.· Sacramento, CAPorter Adventist Hospital, Diagnostic Eye Laboratory· Denver, CODiscover Vision Center· Independence, MO

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