ClinConnect ClinConnect Logo
Search / Trial NCT04657289

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)

Launched by HOFFMANN-LA ROCHE · Dec 1, 2020

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

The Velodrome clinical trial is studying a new way to deliver a treatment called ranibizumab for patients with neovascular age-related macular degeneration (nAMD), a condition that can cause vision loss. This trial will compare giving this treatment every 36 weeks to the usual method, which is every 24 weeks. The goal is to see if the longer interval is just as effective and safe for patients.

To participate, individuals must be at least 50 years old, have been diagnosed with nAMD in the last nine months, and have received at least three prior treatments for their condition. Participants will undergo regular check-ups to monitor their vision and the safety of the treatment. It's important to note that not everyone will qualify; for example, those who have had certain types of eye surgeries or specific eye conditions may be excluded. If eligible, participants can expect a commitment to regular visits over the course of the study, which aims to improve long-term treatment options for nAMD.

Gender

ALL

Eligibility 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 9 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
  • Choroidal neovascularization (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 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

About Hoffmann La Roche

Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.

Locations

Barcelona, , Spain

Paris, , France

Singapore, , Singapore

Newcastle Upon Tyne, , United Kingdom

London, , United Kingdom

Singapore, , Singapore

Gent, , Belgium

Hamburg, , Germany

Kaohsiung, , Taiwan

Leuven, , Belgium

Changhua, , Taiwan

Majadahonda, Madrid, Spain

Bristol, , United Kingdom

Liverpool, , United Kingdom

London, , United Kingdom

Münster, , Germany

Tübingen, , Germany

Hospitalet De Llobregat, Barcelona, Spain

Wolverhampton, , United Kingdom

Seoul, , Korea, Republic Of

Pamplona, Navarra, Spain

Singapore, , Singapore

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Ankara, , Turkey

Barcelona, , Spain

Busan, , Korea, Republic Of

Bruxelles, , Belgium

Cottbus, , Germany

Seongnam Si, , Korea, Republic Of

Liège, , Belgium

London, , United Kingdom

Ludwigshafen, , Germany

Incheon, , Korea, Republic Of

Taipei, , Taiwan

Wien, , Austria

Köln, , Germany

Valladolid, , Spain

Milano, Lombardia, Italy

San Cugat Del Valles, Barcelona, Spain

Sunderland, , United Kingdom

Roma, Lazio, Italy

Dijon, , France

Seoul, , Korea, Republic Of

Haifa, , Israel

Kfar Saba, , Israel

Bonn, , Germany

Tuebingen, , Germany

East Melbourne, Victoria, Australia

Busan, , Korea, Republic Of

Daegu, , Korea, Republic Of

Sydney, New South Wales, Australia

Marseille, , France

Barcelona, , Spain

Southampton, , United Kingdom

Bonn, , Germany

Rosario, , Argentina

Albury, New South Wales, Australia

Creteil, , France

Paris, , France

Köln, , Germany

Münster, , Germany

Münster, , Germany

Roma, Lazio, Italy

Milano, Lombardia, Italy

Barcelona, , Spain

Valladolid, , Spain

Capital Federal, , Argentina

Brisbane, Queensland, Australia

Nedlands, Western Australia, Australia

Wien, , Austria

Bordeaux, , France

Dijon, , France

Lyon Cedex, , France

Marseille, , France

Paris, , France

Freiburg, , Germany

Ludwigshafen, , Germany

München, , Germany

Regensburg, , Germany

Milano, Lombardia, Italy

Milano, Lombardia, Italy

Udine, Veneto, Italy

Pamplona, Navarra, Spain

Ankara, , Turkey

Chieti, Abruzzo, Italy

Sao Paulo, Sp, Brazil

Sydney, New South Wales, Australia

Blumenau, Sc, Brazil

Paris Cedex 19, , France

Jerusalem, , Israel

Kfar Saba, , Israel

Rehovot, , Israel

Tel Aviv, , Israel

Negrar Verona, Veneto, Italy

Seoul, , Korea, Republic Of

Barcelona, , Spain

London, , United Kingdom

Bordeaux, , France

Roma, Rm, Italy

Nantes, , France

Hull, , United Kingdom

Tel Aviv, , Israel

Graz, , Austria

Haifa, , Israel

Petach Tikva, , Israel

Chieti, Abruzzo, Italy

Barcelona, , Spain

Barcelona, , Spain

Madrid, , Spain

Rowville, Victoria, Australia

Goiania, Go, Brazil

Sao Paulo, Sp, Brazil

Sorocaba, Sp, Brazil

Singapore, , Singapore

Singapore, , Singapore

Burjassot, Valencia, Spain

Madrid, , Spain

Binningen, , Switzerland

Taipei, , Taiwan

Taoyuan, , Taiwan

Zhongzheng Dist., , Taiwan

Istanbul, , Turkey

Kocaeli, , Turkey

Madrid, , Spain

Graz, , Austria

Barcelona, , Spain

Zürich, , Switzerland

Capital Federal, , Argentina

Changhua, , Taiwan

Manchester, , United Kingdom

Luzern 16, , Switzerland

Milano, Lombardia, Italy

Roma, Lazio, Italy

Valencia, , Spain

Torino, , Italy

Hurstville, New South Wales, Australia

Hurstville, New South Wales, Australia

Liverpool, New South Wales, Australia

Sao Paulo, Sp, Brazil

Dresden, , Germany

Ulm, , Germany

Singapore, , Singapore

Basel, , Switzerland

Bern, , Switzerland

Lausanne, , Switzerland

Kaohsiung, , Taiwan

Bristol, , United Kingdom

Bonn, , Germany

Cordoba, , Spain

Sulzbach, , Germany

Madrid, , Spain

Ankara, , Turkey

Ankara, , Turkey

Ankara, , Turkey

Negrar Verona, Veneto, Italy

Lausanne, , Switzerland

Kocaeli, , Turkey

Oviedo, Asturias, Spain

Woolloongabba, Queensland, Australia

Hamburg, , Germany

Belo Horizonte, Mg, Brazil

Rio De Janeiro, Rj, Brazil

Sao Paulo, Sp, Brazil

Frankfurt, , Germany

Negrar Di Valpolicella (Vr), Veneto, Italy

Ankara, , Turkey

Bari, Puglia, Italy

Luzern 16, , Switzerland

Bari, Puglia, Italy

Firenze, Toscana, Italy

Sao Paulo, São Paulo, Brazil

Sao Paulo, São Paulo, Brazil

Jerusalem, , Israel

Petach Tikva, , Israel

Rehovot, , Israel

Taoyuan, , Taiwan

Lyon Cedex, , France

Sulzbach, , Germany

Capital Federal, , Argentina

Porto Alegre, Rio Grande Do Sul, Brazil

Miranda, New South Wales, Australia

Blumenau, Santa Catarina, Brazil

Sao Paulo, São Paulo, Brazil

Sorocaba, São Paulo, Brazil

Creteil, , France

Nice, , France

Paris Cedex 19, , France

Cottbus, , Germany

Frankfurt, , Germany

Milano, Lombardia, Italy

Torrette Ancona, Marche, Italy

Negrar Verona, Veneto, Italy

Udine, Veneto, Italy

Basel, , Switzerland

Lausanne, , Switzerland

Zhongzheng Dist., , Taiwan

Ankara, , Turkey

Istanbul, , Turkey

Kocaeli, , Turkey

Toulouse, , France

Perugia, Umbria, Italy

Trieste, Friuli Venezia Giulia, Italy

Sao Paulo, , Brazil

Sao Paulo, , Brazil

Sao Paulo, , Brazil

Sorocaba, , Brazil

Patients applied

0 patients applied

Trial Officials

Clinical Trials

Study Director

Hoffmann-La Roche

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials