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Genetech LADDER Study

TRIAL DESCRIPTION SUMMARY:

Patients diagnosed with age-related wet macular degeneration within 6 months may be eligible for this research clinical trial studying an investigational device that slowly releases Ranibizumab into the eye.  Leading scientists have designed the Port Delivery System for Sustained Delivery of Ranibizumab (PDS).  This surgically implanted, refillable, ocular device releases Lucentis over a period of months.  So the objective of this study is to learn if the Lucentis delivery device, refilled as needed (approximately 4 or 5 time a year) is as effective and well-tolerated as monthly Lucentis injections.

BASIC TRIAL INFORMATION:


Phase:        II
Disease:     Wet Age Related Macular Degeneration
Age:        
Sponsor:    Genentech
Status:       Currently Enrolling
Length:      13 to 31 months

ELEGIBILITY CRITERIA:


Key Inclusion Criteria:

  1. Newly diagnosed wet AMD within 6 months.
  2. Active CNV - subfoveal or juxtafoveal - with subfoveal component.  All subtypes of lesions    are allowed.
  3. Must have received at least 2 prior anti-VEGFs (Avastin, Eylea or Lucentis). Most recent must have been Ranibizumab.
  4. MUST demonstrate anti-VEGF treatment response demonstrated by decrease of OCT Central Field thickness by >50um, or stable or improved BCVA.
  5. Visual acuity (BCVA) of 20/25 to 20/200 in the study eye.
  6. Visual acuity (BCVA) better than 20/200 in the fellow eye.

Key Exclusion Criteria: 

  1. Study-eye and fellow-eye treatment with anti-VEGF agents other than Ranibizumab within 1 month.
  2. RPE tear involving fovea.
  3. Unable to stop anticoagulants/NSAIDS prior to surgery.
  4. Stroke, Heart Attack or Atrial Fibrillation within 3 months.

STUDY TITLE: 

An Efficacy and Safety Study of Surgically Implanted Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab 0.2mg, 0.8mg, or 2mg vs. Monthly Intravitreal Injections of Ranibizumab in Patients with Subfoveal Choroidal Neovascularization from Age Related Macular Degeneration.

TRIAL CONTACT INFORMATION:

Sites: Middleburg Heights
Study Coordinator: Susan Rath
Email:  
srath@retina-assoc.com
Phone: 440-663-0022