ClinicalTrials.Veeva

Menu
The trial is taking place at:
P

Palmetto Retina Center | West Columbia, SC

Veeva-enabled site

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 (Pagoda)

Roche logo

Roche

Status and phase

Active, not recruiting
Phase 3

Conditions

Diabetic Macular Edema

Treatments

Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Drug: Intravitreal Ranibizumab 0.5 mg Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT04108156
GR40550

Details and patient eligibility

About

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).

Enrollment

634 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

634 participants in 2 patient groups

PDS Arm
Experimental group
Description:
Participants randomized to the PDS arm will receive intravitreal ranibizumab injection every 4 weeks (loading phase) and will then have the PDS implant (pre-filled with ranibizumab) surgically inserted. PDS implant refill-exchange procedures will be performed on a fixed interval every 24-weeks (Q24W) thereafter
Treatment:
Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab
Intravitreal Arm
Active Comparator group
Description:
Participants randomized to the intravitreal arm will receive intravitreal ranibizumab injection every 4 weeks until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.
Treatment:
Drug: Intravitreal Ranibizumab 0.5 mg Injection

Trial contacts and locations

88

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems