Study Detail: Genentech HARBOR - wet AMD

Trial Description Summary : This study is to evaluate higher doses of the currently FDA approved drug Lucentis (generic name ranibizumab) in people with newly diagnosed, never treated wet macular degeneration.

Basic Trial Information
    Phase:III 

    Disease: Macular Degeneration   

    Enrollment age limitations: Age 50 and up      

Study Duration: 24 months, plus screening period of approximately 2-4 weeks

Eligibility Criteria
Inclusion Criteria
• BCVA 20/40-20/320
• Treatment naïve, Subfoveal, Classic, Occult, or mixed. (May have extrafoveal or juxtafoveal laser 1 month before screening )
• Minimum Classic or Occult must have one of the following:
  1.Exhibit > 10% increase in lesion by FA comparison with FA from 6 months prior                      
      & w/in 28 days preceding Day 0     OR
  2. VA loss of > 1 Snellen line and occurring anytime w/in prior 6 mos. Before Day 0  
                                                              OR
  3. Subretinal hemorrhage associated with CNV w/in 28 days preceding Day 0
• Total CNV area > 50% of total lesion area based on FA. Total area of lesion <12 disc area of 30.48
• May have received Lucentis or Macugen in NON study eye > 7 days of Day 0.
• Last Avastin in non study eye must be > 3 months from Day 0. Must not continue on Avastin during study.
• Other study criteria as defined by the sponsor, check with the study coordinator
 Exclusion Criteria
• SRH  in study eye that involves center of fovea
• Laser (juxtafoveal or extrafoveal in study eye within 1 month of Day 0.)
• Prior treatment with visudyne, external beam radiation TX or TTT in study eye.
• Previous intravitreal drug delivery in study eye including device implantation, corticosteroid injections
• Previous subfoveal focal laser in study eye.
• Previous study use of anti angiogenic drugs
• Aphakia or absence of posterior capsule in study eye.
• No VH, Inflammation, hx.of RD, idiopathic or autoimmune assoc.uveitis in either eye, MH in study eye.
• Preop or current refraction error of > 8 diopters of myopia.
• Intraocular surgery including cataract surgery in the study eye within 2 months preceding Day 0.
• Uncontrolled glaucoma in study eye (>30 mmHg) despite treatment with medications.
• May not have received Lucentis or Macugen in NON study eye within 7 days of Day 0.
• Treatment with Visudyne in the NON study eye < 7 days preceding Day 0 
• Concurrent use of intravitreal or subtenon corticosteroids in either eye, or oral, IV, or IM
• Previous treatment with Avastin,anecortave,protein kinase C inhibitor,etc in non study eye w/in 3mo of day 0.
• Other concurrent ocular conditions. Check with clinical coordinator
GENERAL MEDICAL EXCLUSION- 
• Uncontrolled BP – Systolic >180 Diastolic >110
• A-Fib not treated within 3 months of screening by PCP.
• Hx of stroke within last 3 months
• Active malignancy
• Allergy to Fluorescein dye.    
• Other exclusions per sponsor – check with clinical coordinator                                                                                      

Study Title  HARBOR Study Protocol FVF4579g”A Phase III, double masked, multicenter, randomzed, active treatment controlled study of the efficacy and safety of 0.5 mg and 2.0 mg ranibizumab administered monthly or on an as needed basis (prn) in patients with subfoveal neovascular ARMD

Contact Information
Site Study Coordinator : Rae Stone
                                           216/831-5704 ext. 253