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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 112
Awards & highlights
PAVILION 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.Check my eligibility
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.See study design
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.
PAVILION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older.
Select...
I have been diagnosed with diabetes (Type 1 or Type 2).
Select...
My diabetic retinopathy is moderately severe to severe.
PAVILION Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with a ≥2-step improvement from baseline on the ETDRS-DRSS at Week 52
Secondary outcome measures
Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured on the ETDRS chart over time
Change from baseline in CST as measured on SD-OCT over time
Sodium dodecyl sulfate
+31 morePAVILION 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.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,880 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
104 Patients Enrolled for Diabetic Retinopathy
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,328 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
104 Patients Enrolled for Diabetic Retinopathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.The study eye must be normal.I do not have uncontrolled high eye pressure or glaucoma needing surgery during the study.I have had laser treatment for my eye condition before.I am 18 years or older.I do not have any eye conditions needing surgery that could affect my vision during the study.Your HbA1c level is less than 12% within 2 months before or at the screening.I have had uveitis before, regardless of the cause.I don't have eye diseases that would make using ranibizumab risky for me.I have active eye inflammation.I don't have any health issues that would make using ranibizumab or getting a PDS implant risky.I have received platelet-rich plasma therapy at any time before being assigned to a treatment group.I have never used medicated eye implants like Ozurdex® or Iluvien®.I suspect or have an eye infection.I am currently on medication for an active infection.I have been diagnosed with significant eye problems affecting my macula.I have never had corticosteroid eye injections.I have never received eye injections for VEGF before.I have never received corticosteroid treatment around my eyes.I have an eye condition that could affect study results.I have severe kidney failure and need or will need dialysis.My blood pressure is not well-controlled.I have not had a stroke or heart attack in the last 6 months.I have been diagnosed with diabetes (Type 1 or Type 2).My diabetic retinopathy is moderately severe to severe.Your vision score is 69 letters or better, which is equal to 20/40 on the eye chart or better.
Research Study Groups:
This trial has the following groups:- Group 1: PDS Arm
- Group 2: Comparator Arm
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT04503551 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the FDA's approval process the same for all PDS Implant Pre-Filled products?
"PDS Implant Pre-Filled with 100 mg/mL Ranibizumab received a safety score of 3. This is due to the fact that Phase 3 trials have both efficacy and safety data supporting their use."
Answered by AI
What is PDS Implant Pre-Filled with 100 mg/mL Ranibizumab indicated to treat?
"PDS Implant Pre-Filled with 100 mg/mL Ranibizumab can be used as an effective treatment for branch vein occlusion, wet age-related macular degeneration (wamd), and macular edema."
Answered by AI
Are researchers still working to enroll more patients in this clinical trial?
"This study is not enrolling patients at the moment. The study was first posted on 8/10/2020 and was last edited on 8/3/2022. However, if you are seeking other studies, there are presently 119 studies actively looking for patients with diabetic retinopathy and 33 studies for PDS Implant Pre-Filled with 100 mg/mL Ranibizumab actively enrolling participants."
Answered by AI
Are there a lot of facilities participating in this clinical research within the state?
"Currently, there are 77 clinical trial sites enrolling patients for this study. While the locations of Oak Forest, Grand Rapids and Baltimore are medical centres participating in the trial, there are many other convenient locations too. If you are thinking of participating in the trial, it would be helpful to select a site that is close to reduce travel time and costs."
Answered by AI
Are there other examples of PDS Implant Pre-Filled with 100 mg/mL Ranibizumab being used in clinical trials?
"The PDS Implant Pre-Filled with 100 mg/mL Ranibizumab was first used in a clinical setting in 2008 at the Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery. As of now, 310 trials have been completed while 33 are ongoing. The majority of these active trials are based in Oak Forest, Illinois."
Answered by AI
How many patients can be enrolled in this clinical trial at one time?
"This study is no longer active. If you're looking for other clinical trials, there are currently 119 studies actively looking for patients with diabetic retinopathy and 33 studies for PDS Implant Pre-Filled with 100 mg/mL Ranibizumab."
Answered by AI
Who else is applying?
What state do they live in?
Florida
California
New York
Other
How old are they?
65+
18 - 65
What site did they apply to?
Kaiser Permanente Riverside Medical Center
Retina & Vitreous of Texas
Barnet Dulaney Perkins Eye Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I want to see better.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Is it for me?
PatientReceived 2+ prior treatments
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