Not currently recruiting at UCSF

This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab (PDS) in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab

a study on Macular Edema

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of the PDS in participants with diabetic macular edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).

Official Title

A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda)

Keywords

Diabetic Macular Edema Port Delivery System Macular Edema Edema Ranibizumab PDS Implant Pre-Filled with 100 mg/mL Ranibizumab Intravitreal Ranibizumab 0.5 mg Injection

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥18 years at time of signing Informed Consent Form
  • Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
  • HbA1c level of ≤10% within 2 months prior to screening or at screening

Study eye

  • Macular thickening secondary to DME involving the center of the fovea with CST ≥325 um on SD-OCT at screening
  • BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent)

You CAN'T join if...

  • High-risk proliferative diabetic retinopathy
  • Active intraocular inflammation (grade trace or above)
  • Suspected or active ocular or periocular infection of either eye
  • Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
  • Cerebrovascular accident or myocardial infarction within 6 months prior to randomization
  • Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
  • Uncontrolled blood pressure

Locations

  • Zuckerberg San Francisco General Hospital not yet accepting patients
    San Francisco California 94110 United States
  • East Bay Retina Consultants accepting new patients
    Oakland California 94609 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04108156
Phase
Phase 3
Study Type
Interventional
Last Updated