Clinical trial registry record

A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.

Plain-language guide

Five questions to ask about this record

What this is
A clinical study registration, not a result or recommendation.
Why it may matter
The registry currently reports Active Not Recruiting.
Evidence
Registered phase 3 study.
Main limitation
Registration does not prove that the intervention works, is safe, or is available to you.
What changed
Registry metadata was last updated July 31, 2026.
Where to verify
Open the primary registry below for eligibility, locations, contacts, and current status.
Registry ID
NCT04657289
Last registry update
July 31, 2026
Status
Active Not Recruiting
Phase
Phase 3
Sponsor
Hoffmann-La Roche
Enrollment
451
Countries
Argentina, Australia, Austria, Belgium, Brazil, France, Germany, Israel, Italy, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Match confidence
100%
Source feed
ClinicalTrials.gov
Automated source synopsis

A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.

Evidence snapshot

What the source actually supports

Evidence stage
Phase 3
Study design
RANDOMIZED · PARALLEL · TREATMENT · SINGLE
Evidence population
Human clinical study registration
Participants
451
Population
ALL · 50 Years
Duration
2021-07-14 to 2027-02-04
Intervention
Ranibizumab; Port Delivery System with Ranibizumab
Comparator
Arm B [Q24W] 24-weeks between refill-exchange procedures
Outcomes measured
Change from baseline in Best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72, as assessed using the…; Change from baseline in BCVA score over time — Baseline up to Week 72; Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over…; Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time — B…; Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over…; Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time — B…; Percentage of participants who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal…; Percentage of participants with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS com…; Mean overall treatment satisfaction at Week 40, as measured by the Macular Disease Treatment Satisfaction Questionnaire…; Percentage of participants who lose = 0 letters in BCVA score from baseline averaged over Weeks 68 and 72 — Baseline to…; Percentage of participants who lose = 0 letters in BCVA score from baseline over time — Baseline up to Week 72; Incidence and severity of ocular and systemic (non-ocular) adverse events in the Q36W and Q24W arms — Baseline up to We…; Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special int…; Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (≤ 37 da…; Incidence and severity of adverse device effects in the Q36W and Q24W arms — Baseline up to Week 72; Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms —…; Change from baseline in center point thickness (CPT) up to and including Week 72 — Baseline up to Week 72; Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each r…; Observed serum concentration of ranibizumab at specified timepoints — Baseline to Week 72; Incidence of treatment-emergent ADAs during the study — Baseline to Week 72
Reported result
No reusable finding-level result is available in this record.

Main limitationThis is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.

Safety and approvalEligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians. Trial registration is not regulatory approval and does not establish that an intervention is available.

Source supportStructured registry protocol metadata; no finding-level conclusion is generated.

Trial stage · Phase 3A trial phase describes development stage; it does not establish a positive result.
Phase 1Phase 2Phase 3Phase 4

Registration and recruitment status do not establish safety, efficacy, or regulatory approval.

Why this record appears here · 100% topic match

The title, summary, or source keywords matched one or more topics followed by immortal.life. A higher percentage means a stronger topic match; it does not rate safety, effectiveness, or study quality.

  • Vision ageing · 100%Title contains controlled term: age-related macular degeneration. Abstract contains controlled term: age-related macular degeneration. Source terminology contains: age-related macular degeneration. Title supplies longevity context: age-related. Study type is explicitly identified as INTERVENTIONAL.

Automated source check 100% · update recency 100%. These figures help sort records; they are not medical ratings.