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Monoclonal Antibodies

PDS with Ranibizumab vs. Intravitreal Ranibizumab for Diabetic Macular Edema (Pagoda Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years at time of signing Informed Consent Form

Macular thickening secondary to DME involving the center of the fovea with CST ≥325 um on SD-OCT at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 48, week 96

Awards & highlights

Pagoda Trial Summary

This trial will compare the effects of two different ways of delivering a drug to treat diabetic macular edema. One group will receive the drug every four weeks, and the other group will receive the drug every 24 weeks.

Who is the study for?

This trial is for adults over 18 with Diabetic Macular Edema (DME) showing specific retina swelling, a certain vision score range, and controlled diabetes. It's not for those with recent severe heart or brain events, uncontrolled eye pressure or glaucoma, recent worsening of atrial fibrillation, uncontrolled blood pressure, or eye infections.Check my eligibility

What is being tested?

The study compares two treatments: a Port Delivery System with Ranibizumab (PDS), given every 24 weeks versus standard ranibizumab injections into the eye every 4 weeks. The goal is to see if PDS can be as effective but less frequent.See study design

What are the potential side effects?

Possible side effects include inflammation inside the eye, increased eye pressure which may lead to glaucoma, bleeding in the eyes, cataract formation and potential infection risk at the implant site.

Pagoda Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My eye condition involves swelling in the center of my vision.

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I have been diagnosed with diabetes (Type 1 or Type 2).

Pagoda Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 48, week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 48, week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 48, week 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in BCVA score from baseline averaged over Weeks 60 and 64 as measured using the ETDRS chart in the efficacy population using a treatment policy strategy for all intercurrent events

Secondary outcome measures

Change from baseline in BCVA as measured on the ETDRS chart over time

Change from baseline in CST as measured on SD-OCT over time

Change from baseline in ETDRS-DRSS score over time

+37 more

Pagoda Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PDS ArmExperimental Treatment1 Intervention

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

Group II: Intravitreal ArmActive Control1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,430 Previous Clinical Trials

1,088,776 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,098 Total Patients Enrolled

Media Library

Intravitreal Ranibizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04108156 — Phase 3

Diabetic Macular Edema Research Study Groups: PDS Arm, Intravitreal Arm

Diabetic Macular Edema Clinical Trial 2023: Intravitreal Ranibizumab Highlights & Side Effects. Trial Name: NCT04108156 — Phase 3

Intravitreal Ranibizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04108156 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the FDA-approved indications for PDS Implant Pre-Filled with 100 mg/mL Ranibizumab?

"PDS Implant Pre-Filled with 100 mg/mL Ranibizumab is most often used to treat branch vein occlusion. However, it can also be used as a wet age-related macular degeneration (wamd) treatment, for macular edema, and myopic choroidal neovascularization."

Answered by AI

At how many distinct hospitals is this trial being conducted?

"This trial is being conducted in a few central locations, such as Austin Research Center for Retina in Austin, Texas Retina Associates in Dallas, Retina Vit Surgeons/Central NY in Syracuse, and 98 other medical centres."

Answered by AI

How many people will be given this new medicine to try?

"This study is not currently looking for new participants. The listing for this trial was first posted on September 30th, 2019 and edited as recently as August 11th, 2022. If you are seeking other studies, there are 119 trials for diabetic macular edema (dme) and 33 PDS Implant Pre-Filled with 100 mg/mL Ranibizumab studies that are currently admitting patients."

Answered by AI

Are there any dangers to patients associated with the PDS Implant Pre-Filled with 100 mg/mL Ranibizumab?

"PDS Implant Pre-Filled with 100 mg/mL Ranibizumab is considered safe and received a score of 3."

Answered by AI

Are there other ongoing studies that are experimenting with PDS Implant Pre-Filled and 100 mg/mL Ranibizumab?

"There are a total of 33 active clinical trials for PDS Implant Pre-Filled with 100 mg/mL Ranibizumab. Of these, 16 are in Phase 3. The largest number of trials for this medication are taking place in Oak Forest, Illinois, however there are 941 locations running clinical trials for PDS Implant Pre-Filled with 100 mg/mL Ranibizumab."

Answered by AI

Who else is applying?

What site did they apply to?

Retina Group of Florida

University Retina and Macula Associates, PC

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

Why did patients apply to this trial?

Because I have diabetic retinopathy and have had eye bleeds in the left eye particularly and have had a series of 7 shots in that eye. Haven't had any in awhile but if I can help by being in a medical drug trial, I willing to give it a go.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

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

2019. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04108156.

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