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Summary

for people ages 50 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This is a Phase II clinical study to evaluate the efficacy, safety and pharmacokinetics of three different formulations of ranibizumab delivered via RPDS implant compared with the standard of care (SOC) intravitreal (ITV) injections of ranibizumab, in participants with subfoveal neovascular AMD.

Official Title

A Phase II, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration

Keywords

Macular Degeneration Ranibizumab

Eligibility

You can join if…

Open to people ages 50 years and up

  • Newly diagnosed with wet AMD within 9 months of screening visit
  • Participant must have received at least 2 prior ITV anti-vascular endothelial growth factor (VEGF) injections. However, the most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit
  • Demonstrated response to prior ITV anti-VEGF treatment
  • Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study(ETDRS) charts of 20/20-20/200 Snellen equivalent

You CAN'T join if...

  • Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
  • Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit
  • History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD in the study eye
  • Prior participation in a clinical trial involving anti-angiogenic drugs, other than ranibizumab, in either eye within 2 months of the randomization visit
  • Subretinal hemorrhage in the study eye that involves the center of the fovea
  • Subfoveal fibrosis, or atrophy in the study eye
  • Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Uncontrolled ocular hypertension or glaucoma in the study eye
  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye
  • Uncontrolled blood pressure
  • Uncontrolled atrial fibrillation within 3 months of informed consent
  • History of myocardial infarction or stroke within the last 3 months prior to informed consent
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant, that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications
  • Use of oral corticosteroids
  • Current treatment for any active systemic infection
  • Use of anticoagulants, anti-platelets (other than aspirin), or medications known to exert similar effects
  • Active malignancy within 12 months of randomization
  • History of allergy to fluorescein
  • Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)

Locations

  • West Coast Retina Medical Group accepting new patients
    San Francisco, California, 94109, United States
  • N CA Retina Vitreous Assoc accepting new patients
    Mountain View, California, 94040, United States
  • Retinal Consultants Med Group accepting new patients
    Sacramento, California, 95841, United States
  • California Retina Consultants not yet accepting patients
    Bakersfield, California, 93309, United States
  • California Retina Consultants accepting new patients
    Santa Barbara, California, 93103, United States
  • Miramar Eye Specialists accepting new patients
    Ventura, California, 93003, United States
  • Sierra Eye Associates accepting new patients
    Reno, Nevada, 89502, United States
  • The Retina Partners accepting new patients
    Encino, California, United States
  • Jules Stein Eye Institute/ UCLA accepting new patients
    Los Angeles, California, 90095-7000, United States
  • Orange County Retina Med Group accepting new patients
    Santa Ana, California, 92705, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT02510794
Phase
Phase 2
Lead Scientist
Robert Bhisitkul
Study Type
Interventional
Last Updated
August 1, 2017
I’m interested in this study!