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Monoclonal Antibodies

Ranibizumab PDS Implant for Diabetic Retinopathy (PAVILION 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

Documented diagnosis of diabetes mellitus (Type 1 or Type 2)

Must not have

Active intraocular inflammation (grade trace or above)

Presence of center-involved diabetic macular edema (defined as CST ≥325 µm)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to week 112

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying the effects of ranibizumab given through the Port Delivery System in people with diabetic retinopathy without center-involved diabetic macular edema.

Who is the study for?

Adults over 18 with diabetic retinopathy but no macular edema can join. They must have a certain level of retina damage and controlled diabetes (HbA1c ≤12%). Excluded are those with prior eye treatments like corticosteroids or anti-VEGF, recent heart issues, uncontrolled glaucoma, infections, or conditions needing future eye surgery.

What is being tested?

The trial tests a new way to deliver Ranibizumab for diabetic retinopathy using a Port Delivery System (PDS) implant compared to regular injections into the eye. It aims to see if PDS is as effective and safe as standard treatment.

What are the potential side effects?

Possible side effects include eye irritation or infection, increased eye pressure, bleeding inside the eye, cataracts formation, and allergic reactions. There may also be systemic effects due to medication absorption.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years or older.

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

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My diabetic retinopathy is moderately severe to severe.

Exclusion Criteria

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

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I have active eye inflammation.

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

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I have had surgery for glaucoma.

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I have had laser treatment for my eye condition before.

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I do not have any eye conditions needing surgery that could affect my vision during the study.

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I have had uveitis before, regardless of the cause.

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I have received platelet-rich plasma therapy at any time before being assigned to a treatment group.

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I have never used medicated eye implants like Ozurdex® or Iluvien®.

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I suspect or have an eye infection.

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I am currently on medication for an active infection.

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I have been diagnosed with significant eye problems affecting my macula.

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I have never had corticosteroid eye injections.

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I have never received eye injections for VEGF before.

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I have never received corticosteroid treatment around my eyes.

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I have severe kidney failure and need or will need dialysis.

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My blood pressure is not well-controlled.

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I have not had a stroke or heart attack in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 112

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 112

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 112 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 52

Secondary study objectives

Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured on the ETDRS chart over time

Rate of participants developing a vision-threatening complication (defined as PDR, ASNV, or CI-DME [defined as central foveal thickness [CST] ≥325 μm on spectral-domain optical coherence tomography [SD-OCT]) through Week 52

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

2Treatment groups

Experimental Treatment

Group I: PDS ArmExperimental Treatment2 Interventions

Participants randomized to the PDS arm will receive two intravitreal ranibizumab injections 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 36-weeks (Q36W) thereafter

Group II: Comparator ArmExperimental Treatment2 Interventions

Participants randomized to the comparator arm will undergo study visits every 4 weeks (Q4W) for comprehensive clinical monitoring until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q36W thereafter. Participants will be eligible to receive intravitreal ranibizumab 0.5 mg injections if treatment eligibility criteria are met.

0 / 20Eligibility criteria met