This study is in progress, not accepting new patients

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

a study on Diabetes Macular Edema

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (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
    San Francisco California 94110 United States
  • Retina-Vitreous Associates Medical Group
    Beverly Hills California 90211 United States
  • The Retina Partners
    Encino California 91436 United States
  • Orange County Retina Med Group
    Santa Ana California 92705 United States
  • East Bay Retina Consultants
    Oakland California 94609 United States
  • Doheny Eye Institute
    Pasadena California 91105 United States
  • Retina Consultants of Orange County
    Fullerton California 92835-3424 United States
  • Retinal Consultants Med Group
    Sacramento California 95825 United States
  • California Eye Specialists Medical group Inc.
    Pasadena California 91107 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04108156
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 634 people participating
Last Updated