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Monoclonal Antibodies
PDS Implant with Ranibizumab for Age-Related Macular Degeneration (Portal Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability and willingness to undertake all scheduled visits and assessments
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 240
Awards & highlights
Portal Trial Summary
This trial will study the long-term effects of a treatment for neovascular age-related macular degeneration.
Who is the study for?
This trial is for patients with neovascular age-related macular degeneration who completed certain previous studies (Ladder, Archway, or Velodrome) without early discontinuation. Participants must be able to attend all visits and assessments. Women of childbearing potential must agree to use contraception or remain abstinent.Check my eligibility
What is being tested?
The study tests the long-term safety of a Port Delivery System with ranibizumab (PDS), which is an implant designed to continuously deliver medication for treating nAMD over an extended period without frequent injections.See study design
What are the potential side effects?
Possible side effects include eye irritation, increased risk of eye infection, bleeding inside the eye, retinal detachment, cataracts and floaters. There may also be general reactions like headache or nausea.
Portal Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can attend all appointments and follow study procedures.
Portal Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 240
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 240
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and Severity of Adverse Device Effects
Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects
+3 moreSecondary outcome measures
Change from Baseline in Center Point Thickness Over Time
Change in Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters
Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time
+13 morePortal Trial Design
7Treatment groups
Experimental Treatment
Group I: PDS Implant Cohort 7 (ex-US only)Experimental Treatment1 Intervention
Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W
Group II: PDS Implant Cohort 6 (ex-US only)Experimental Treatment1 Intervention
Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W
Group III: PDS Implant Cohort 5 (ex-US only)Experimental Treatment1 Intervention
Participants from Study WR42221 who completed Week 24 but were not eligible to be randomized within WR42221 and who will be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W
Group IV: PDS Implant Cohort 4 (US only)Experimental Treatment1 Intervention
Participants in the intravitreal ranibizumab arm of Study GR40548 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240.
Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.
Group V: PDS Implant Cohort 3 (US only)Experimental Treatment1 Intervention
Participants in the intravitreal ranibizumab arm of Study GX28228 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240.
Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.
Group VI: PDS Implant Cohort 2 (US only)Experimental Treatment1 Intervention
Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240.
Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.
Group VII: PDS Implant Cohort 1 (US only)Experimental Treatment1 Intervention
Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240.
Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,068 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,940 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, nor planning to become pregnant soon.I am not on any medications listed in the 'Prohibited Therapy'.I don't have eye diseases that would make using ranibizumab risky for me.I don't have any health conditions that would make using ranibizumab or getting an Implant risky.I can attend all appointments and follow study procedures.
Research Study Groups:
This trial has the following groups:- Group 1: PDS Implant Cohort 3 (US only)
- Group 2: PDS Implant Cohort 4 (US only)
- Group 3: PDS Implant Cohort 1 (US only)
- Group 4: PDS Implant Cohort 2 (US only)
- Group 5: PDS Implant Cohort 5 (ex-US only)
- Group 6: PDS Implant Cohort 6 (ex-US only)
- Group 7: PDS Implant Cohort 7 (ex-US only)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with PDS Implantation and the use of Ranibizumab 100mg/mL?
"PDS Implant with Ranibizumab 100 mg/mL is estimated to be a safe 3 because it is a Phase 3 trial. This designation means that, in addition to efficacy, there is also data supporting safety from multiple rounds of testing."
Answered by AI
Which medical conditions are commonly helped by PDS Implant with Ranibizumab 100 mg/mL?
"PDS Implant with Ranibizumab 100 mg/mL is commonly used to branch vein occlusion, but it can also help patients with wet age-related macular degeneration (wamd), macular edema, and myopic choroidal neovascularization."
Answered by AI
Are there comparable reports to the one involving PDS Implant with Ranibizumab 100 mg/mL?
"The PDS Implant with Ranibizumab 100 mg/mL was first trialled in 2008 at Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery. Since then, 310 clinical trials have completed. As of right now, there are 33 active clinical trials, with a large number of them based in Shawnee Mission, Kansas."
Answered by AI
At how many establishments is this investigation being conducted?
"Currently, this trial is being conducted at 6 sites. They are Shawnee Mission, Grand Rapids, Lemont and 6 other locations. To try and make the process more convenient for patients, please choose the site that is closest to your location."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Retina Consultants, San Diego
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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