Phase IIIb Study of 36-Week Refill Exchanges of Port Delivery System with Ranibizumab in nAMD
EU CTIS ID: 2024-516924-32-00
What this study is testing
To evaluate the effectiveness of the Port Delivery System with ranibizumab (PDS) administered Q36W
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 50 years at time of signing Informed Consent Form
- Initial diagnosis of nAMD within 24 months prior to the screening visit (according to recruitment strategy, a minimum of 50% [~125] patients diagnosed within 9 months prior to screening will be enrolled
- Demonstrated response to prior anti-vascular endothelial growth factor (VEGF) intravitreal (IVT) treatment since diagnosis
- nAMD disease stability detected per optical coherence tomography (OCT) at time of enrollment, as assessed by the investigator and confirmed by the central reading center (CRC)
- Best-Corrected Visual Acuity (BCVA) of 34 letters or better (20/200 or better approximate Snellen equivalent),using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters (see the BCVA manual for additional details) at screening and enrollment visits
- Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
You likely can't join if
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
- Prior pars plana vitrectomy surgery
- Prior treatment with Visudyne® (verteporfin for injection), external-beam radiation therapy, or transpupillary thermotherapy
- The presence of subfoveal fibrosis or subfoveal atrophy in the study eye
- Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the superotemporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
- Previous intraocular device implantation (not including intraocular lens implants)
The study team makes the final eligibility decision.
Where it's taking place
- Italy
- Germany
- France
- Spain
- Czechia
- Austria
- Denmark
- Greece
- Poland
- Canada
- Thailand
- Switzerland
- United Kingdom
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Italy; Germany; France; Spain; Czechia; Austria and 8 more locations. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.