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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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