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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

Must not have

Suspected or active ocular or periocular infection of either eye

Active intraocular inflammation (grade trace or above)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up , baseline week 48, week 96

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I suspect or have an eye infection.

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I have active eye inflammation.

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I have a severe form of diabetic eye disease.

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My blood pressure is not well-controlled.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in BCVA Score from Baseline Averaged Over Weeks 60 and 64 as Measured With Use of the ETDRS Chart in the Modified Intent-To-Treat (mITT) Population Using a Treatment Policy Strategy for All Intercurrent Events

Patient-reported Vision-Related Functioning and Health-Related Quality of Life (HRQoL) Among Patients in Both Treatment Arms, as Measured by Changes from Baseline

Percentage of Participants Who Report Preferring PDS Treatment Compared with Intravitreal Ranibizumab Treatment

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Substudy: Cohort 2bExperimental Treatment1 Intervention

Participants who received an updated PDS implant, have \< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, will undergo one refill-exchange procedure (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit.

Group II: Substudy: Cohort 2aExperimental Treatment1 Intervention

Participants who received an updated PDS implant, have \< 24 weeks post-re-implantation follow-up and no refill exchange visit in the main study, will undergo two refill-exchange procedures (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit.

Group III: Substudy: Cohort 1Experimental Treatment2 Interventions

Participants will undergo re-implantation with the updated PDS implant (pre-filled with ranibizumab 100 mg/mL) on Day 1 (or enrollment visit) and then will have two refill-exchanges (ranibizumab 100 mg/mL) Q24W up to 48 weeks.

Group IV: PDS ArmExperimental Treatment2 Interventions

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 V: Intravitreal ArmActive Control2 Interventions

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 / 7Eligibility criteria met