At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- PDS Implant with Ranibizumab 100 mg/mL (drug)
- How long the study runs
- Study runs about 135 months (dates as stated)
- About the drug or intervention
- PDS Implant with Ranibizumab 100 mg/mL — drug: Will be administered as per the schedule described in individual arm
- Patient visit burden
- "This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 1,000
- Started
- 2018-09-20
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for neovascular age-related macular degeneration
- • Phase3 - 1,000 participants
- • This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with neovascular age-related macular degeneration
Where?
- • Bristol - Bristol Eye Hospital
- • Liverpool - Royal Liverpool University Hospital
- • London - Moorfields Eye Hospital NHS Foundation Trust
- • London - Central Middlesex Hospital
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.
More detail
The Transscleral Photocoagulation sub-study (sub-study 1) will evaluate the effectiveness of using transscleral photocoagulation (TPC) with the Iridex laser system to mitigate vitreous hemorrhages secondary to the Port Delivery System with ranibizumab (PDS) implantation procedure in participants with neovascular age-related macular degeneration (nAMD). The sub-study will enroll about 55 participants. The Re-implantation sub-study (sub-study 2) will evaluate the safety of re-implantation with the updated PDS with ranibizumab . Up to 100 participants who previously participated in the main study in the United States will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years and over
- Who can join: All genders
What the study is looking for
- ✓Ability and willingness to undertake all scheduled visits and assessments
- ✓For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
Who cannot take part
- ✗Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"
- ✗Sub-study 1
- ✗Inclusion Criteria
- ✗\- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use...
- ✗Participants must meet the following ocular criteria for the study eye for substudy entry:
See the full criteria
Where Is This Study? (8 UK sites)
Bristol Eye Hospital
Bristol BS1 2LX, United Kingdom
Royal Liverpool University Hospital
Liverpool L7 8XP, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London EC1V 2PD, United Kingdom
Research Portfolio Managers- Daniela Narvaez, Anika Kadchha, Abi Chandrakumar, Xin Liu
moorfields.resadmin@nhs.net0207 566 2036Central Middlesex Hospital
London NW10 7NS, United Kingdom
Kings College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne NE1 4LP, United Kingdom
Sunderland Eye Infirmary
Sunderland SR2 9HP, United Kingdom
Royal Wolverhampton hospital
Wolverhampton WV10 0QP, United Kingdom
How to Get in Touch
Reference Study ID Number: GR40549 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
