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Evaluating a new delivery system for treating eye disease

A Phase IIIb, Global, Multicenter, Randomized, Visual Assessor-Masked 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)

Phase 3 Interventional Hoffmann-La Roche · NCT04657289

This study is testing if a new way to deliver eye treatment can safely help people with a specific type of age-related vision loss go longer between doses compared to the usual schedule.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment442 (estimated)
Ages50 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsranibizumab, brolucizumab, radiation
Locations123 sites (Capital Federal and 122 other locations)
Trial IDNCT04657289 on ClinicalTrials.gov

What this trial studies

This Phase IIIb clinical trial assesses the efficacy, safety, and pharmacokinetics of a Port Delivery System that administers ranibizumab every 36 weeks compared to every 24 weeks in patients with neovascular age-related macular degeneration (nAMD). The study is multicenter and randomized, with visual assessors masked to treatment allocation. Participants must have a history of nAMD and prior response to anti-VEGF treatments. The goal is to determine if the longer refill regimen is as effective and safe as the standard regimen.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with a recent diagnosis of nAMD and a history of response to anti-VEGF treatments.

Not a fit: Patients who have undergone certain eye surgeries or treatments for AMD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less frequent treatment option for patients with nAMD, potentially improving adherence and quality of life.

How similar studies have performed: Other studies have shown promise with similar delivery systems, but this specific approach is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥ 50 years at time of signing Informed Consent Form
* Initial diagnosis of nAMD within 9 months prior to the screening visit
* 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
* Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
* Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment
* BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better

Exclusion Criteria:

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
* Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
* Previous treatment with corticosteroid intravitreal injection, intraocular device implantation, previous laser (any type) used for AMD treatment in study eye
* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit in study eye
* Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
* Prior treatment with brolucizumab (at any time prior to the screening visit) in either eye
* Prior participation in a clinical trial involving any anti-VEGF drugs, within 6 months prior to the enrollment visit in either eye
* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is \>0.5 disc area at screening in study eye
* Subfoveal fibrosis or subfoveal atrophy in study eye
* CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia in either eye
* Retinal pigment epithelial tear in study eye
* Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results in study eye
* Active intraocular inflammation in study eye
* History of vitreous hemorrhage in study eye
* History of rhegmatogenous retinal detachment in study eye
* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit in study eye
* History of pars plana vitrectomy surgery
* Aphakia or absence of the posterior capsule in study eye
* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in study eye
* Preoperative refractive error that exceeded 8 diopters of myopia, for Participants who have undergone prior refractive or cataract surgery in study eye
* Intraocular surgery within 3 months preceding the enrollment visit in study eye
* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study in study eye
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in study eye
* History of corneal transplant in study eye
* Any history of uveitis requiring treatment in either eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled blood pressure
* History of stroke within the last 3 months prior to informed consent
* Atrial fibrillation diagnosed or worsened within the last 3 months prior to informed consent
* History of myocardial infarction within the last 3 months prior to informed consent,
* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator
* Confirmed active systemic infection
* Use of any systemic anti-VEGF agents
* Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of \<= 6 and a stable prostate-specific antigen for \> 12 months
* Previous participation in any non-ocular disease studies of investigational drugs within 1 month preceding the informed consent
* Non-functioning non-study eye

Where this trial is running

Capital Federal and 122 other locations

+73 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neovascular Age-related Macular Degeneration
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.