BridgeMD
A Study of the Efficacy, Safety, and Pharmacokinetics of A 36-Week Refill Regimen for the Port Delivery System with Ranibizumab in Patients with Wet Age-Related Macular Degeneration (Velodrome)
EU CTIS ID: 2023-507130-24-00
What this study is testing
To evaluate the efficacy of ranibizumab 100 mg/mL delivered via the port delivery system with ranibizumab (PDS) every 36 weeks (Q36W) compared with every 24 weeks (Q24W) on the basis of change from baseline in best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72
- 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
- Ocular inclusion criteria: Initial diagnosis nAMD within 9 months prior to the screening visit
- Ocular inclusion criteria: Previous treatment with at least three anti- vascular endothelial growth factor (VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
- Ocular inclusion criteria: Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment
- Ocular inclusion criteria: BCVA of 34 letters or better, using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment visits
- Ocular inclusion criteria: With any subtype of nAMD lesions - nAMD lesions at the time of diagnosis must involve the macula (6-mm diameter centered at the fovea)
- Ocular inclusion criteria: Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography, fluorescein angiography, fundus autofluorescence image, and OCT images
You likely can't join if
- Prior Ocular Treatment: Study Eye History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- Prior Ocular Treatment: Either Eye Prior participation in a clinical trial involving any therapies for nAMD, within 9 months from the time of nAMD diagnosis
- CNV Lesion Characteristics: Study Eye Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area in size at screening
- Concurrent Systemic Conditions: Uncontrolled blood pressure
- Concurrent Systemic Conditions: Use of any systemic anti-VEGF agents
- Concurrent Systemic Conditions: Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Israel
- Brazil
- Taiwan
- United Kingdom
- Korea, Republic of
- Singapore
- Argentina
- Switzerland
- Turkey
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 - 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Israel; Brazil; Taiwan; United Kingdom; Korea, Republic of and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.