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Summary

Eligibility
for people ages 50 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a Phase II clinical study to evaluate the efficacy, safety and pharmacokinetics of three different formulations of ranibizumab delivered via the Ranibizumab Port Delivery System (RPDS) implant compared with the standard of care (SOC) intravitreal (ITV) injections of ranibizumab, in participants with subfoveal neovascular age-related macular degeneration (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

  • Age over 50 years
  • Newly diagnosed with wet AMD within 6 months of screening visit
  • Participant must have received at least 2 prior anti-VEGF injections. The most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit
  • Participant may have received up to 6 ITV anti-Vascular Endothelial Growth factor(VEGF) injections prior to the screening visit
  • Demonstrated response to prior SOC ITV anti-VEGF treatment
  • Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study(ETDRS) charts of 20/25-20/200 Snellen equivalent at the screening visit
  • Willingness and ability to provide signed informed consent

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
  • 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

  • San Francisco, California, 94109, United States
  • Mountain View, California, 94040, United States
  • Sacramento, California, 95841, United States
  • Santa Barbara, California, 93103, United States
  • Ventura, California, 93003, United States
  • Encino, California, United States
  • Los Angeles, California, 90095-7000, United States
  • 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
October 1, 2016
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