Ranibizumab PDS Implant for Diabetic Retinopathy

(PAVILION Trial)

No longer recruiting at 2 trial locations

Overseen By Reference Study ID Number: GR41675 www.roche.com/about_roche/roche_worldwide.htm

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Uncontrolled blood pressure, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 4

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating diabetic retinopathy, a common eye issue in people with diabetes that can lead to vision loss. The study compares two treatments: one group receives a Ranibizumab implant (PDS Implant Pre-Filled with 100 mg/mL Ranibizumab), while the other group receives regular eye injections of the same medicine (Intravitreal Ranibizumab 0.5 mg Injection). The researchers aim to determine if the implant can maintain vision stability as well as, or better than, the injections. Individuals with diabetes diagnosed with certain levels of diabetic retinopathy, without significant eye swelling, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the PDS implant is safe for diabetic retinopathy?

Research has shown that the Port Delivery System (PDS) with ranibizumab is generally well-tolerated. In studies on diabetic eye conditions, patients receiving ranibizumab through PDS every 24 weeks reported positive experiences. The treatment proved effective, with most individuals not experiencing serious side effects. Some reported minor issues like eye irritation or redness, but these were uncommon.

For ranibizumab injections directly into the eye, past patients demonstrated that the treatment is safe and well-tolerated. These injections have been used for other eye conditions, with most individuals experiencing only mild and temporary side effects, such as slight discomfort or a feeling of pressure in the eye.

Both the PDS with ranibizumab and the ranibizumab injections have undergone safety studies. Evidence indicates they are generally safe options for managing diabetic retinopathy, with only minor side effects reported by most participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for diabetic retinopathy, which usually involves regular intravitreal injections, the Ranibizumab PDS Implant offers a novel delivery method. This implant is surgically inserted and allows for a slow, sustained release of the medication, potentially reducing the frequency of treatments to every 36 weeks. Researchers are excited about this treatment because it could significantly ease the treatment burden for patients, offering a more convenient and less invasive option compared to frequent injections. This innovation might improve patient adherence and overall outcomes by ensuring consistent drug delivery over extended periods.

What evidence suggests that this trial's treatments could be effective for diabetic retinopathy?

Research has shown that using a Port Delivery System (PDS) to deliver ranibizumab effectively treats eye conditions like diabetic macular edema (DME). In this trial, participants in the PDS arm will receive the PDS implant pre-filled with ranibizumab, providing a steady supply of the medication every 36 weeks. This approach matches the effectiveness of monthly injections in maintaining vision. Patients using the PDS experienced similar vision improvements to those receiving regular injections. The treatment is generally well-tolerated, with any temporary vision changes typically resolving within a few weeks after device implantation. Overall, the PDS with ranibizumab shows promise for managing diabetic retinopathy without frequent injections. ^{2 6 7 8 9}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The study eye must be normal.

Your HbA1c level is less than 12% within 2 months before or at the screening.

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

Exclusion Criteria

I was diagnosed with or my atrial fibrillation worsened in the last 6 months.

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

I have had surgery for glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PDS implant with ranibizumab and undergo refill-exchange procedures every 36 weeks

52 weeks

Visits every 4 weeks for clinical monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 weeks

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

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.

How Is the Trial Designed?

Group I: PDS Arm Experimental Treatment 2 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 Arm Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1.

retinalphysician.com

retinalphysician.com/issues/2025/september/the-port-delivery-system-in-the-paradigm/

The Port Delivery System in the Paradigm

In that study, patients implanted with the PDS refilled every 6 months achieved noninferior improvements in vision compared to those receiving ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02510794

NCT02510794 | Study of the Efficacy and Safety ...

Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age ...

3.

jamanetwork.com

jamanetwork.com/journals/jamaophthalmology/fullarticle/2830898

Continuous Ranibizumab via Port Delivery System vs ...

Continuous ranibizumab every 24 weeks via PDS provided effective and generally well-tolerated treatment for DME with retreatments every 6 months through at ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11886869/

Continuous Ranibizumab via Port Delivery System vs Monthly ...

Continuous ranibizumab every 24 weeks via PDS provided effective and generally well-tolerated treatment for DME with retreatments every 6 months ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11886866/

Port Delivery System With Ranibizumab vs Monitoring in ...

With PDS, vision decreased transiently 4 weeks after implantation, resolving 8 weeks after that; no vision change from baseline occurred in ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04108156

NCT04108156 | A Study to Evaluate Efficacy, Safety & ...

This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10776525/

Clinical Trials and Future Outlooks of the Port Delivery System ...

This narrative review provides a much-needed overview of existing clinical trials as well as ongoing and upcoming trials investigating PDS with RBZ.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04503551

NCT04503551 | A Multicenter, Randomized Study in ...

A Phase III, Multicenter, Randomized Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic ...

9.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/258905

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of ...

This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every ...