Ranibizumab PDS Implant for Diabetic Retinopathy

(PAVILION Trial)

Recruiting at 1 trial location

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

174 Participants Needed

Trial Summary

What is the purpose of this trial?

Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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