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RECRUITING Phase 3 ClinicalTrials.gov

Extension Study for the Port Delivery System With Ranibizumab (Portal)

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT03683251

Registry updated: 2026-09-28
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Description

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.

Interventions

  • PDS Implant with Ranibizumab 100 mg/mL (Drug)
    Will be administered as per the schedule described in individual arm

Eligibility criteria

Inclusion Criteria: * Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm) * Ability and willingness to undertake all scheduled visits and assessments * For women of childbearing potential: agreement to remain abstinent or use contraceptive measures Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab * History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications * History of other diseases, 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 that renders the participant at high risk of treatment complications * Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy" Sub-study 1 Inclusion Criteria \- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures Participants must meet the following ocular criteria for the study eye for substudy entry: * Diagnosis of exudative nAMD within 2 years prior to the enrollment visit * Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit * Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following: Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA) * All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea). * Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP and SD-OCT images. Exclusion Criteria Prior Ocular Treatments Study Eye * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD * Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy * Previous treatment with corticosteroid ITV injection * Previous intraocular device implantation * Previous laser (any type) used for AMD treatment Either Eye * Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit * Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab CNV Lesion Charateristics Study Eye * Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening * Subfoveal fibrosis or subfoveal atrophy Either Eye \- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Concurrent Ocular Conditions Study Eye * Retinal pigment epithelial tear * Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) 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 * Active intraocular inflammation (grade trace or above) * History of vitreous hemorrhage * History of rhegmatogenous retinal detachment * History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit * Aphakia or absence of the posterior capsule * Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation. * Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia * Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye * Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit * Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery * History of corneal transplant * History of prior vitrectomy surgery and absence of posterior capsule Either Eye * History of idiopathic or autoimmune-associated uveitis * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis Concurrent Systemic Conditions * Inability to comply with study schedule or procedures as described in the study protocol * Uncontrolled blood pressure * History of stroke within the last 3 months prior to informed consent * Uncontrolled atrial fibrillation within 3 months of 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 patient at high risk of treatment complications in the opinion of the investigator * Current systemic treatment for a confirmed active systemic infection * Use of any systemic anti-VEGF agents * Chronic use of oral corticosteroids * Active cancer within 12 months of enrollment * Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals) * Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit * History of albinism * Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab Sub-study 2 Inclusion Criteria: * Having experienced septum dislodgement in the original implant while in the main study or after exiting the main study Ocular Inclusion Criteria for Study Eye * Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center Exclusion Criteria (Cohort 1 only): Concurrent Ocular Conditions-Study Eye * Any ocular condition that may render the patient at high risk for surgical or treatment complications * Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit * Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment * History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit * Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss * Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant * Ongoing ocular complications that might affect participant safety Concurrent Ocular Conditions-Either Eye * Suspected or active ocular or periocular infection * Any history of uveitis * Active blepharitis Concurrent Systemic Conditions * Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications * Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer * Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in the main study GR40549) within 6 months prior to enrollment. * Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.

Conditions

Neovascular Age-Related Macular Degeneration

Locations

  • Retinal Research Institute, LLC — Phoenix, Arizona, United States
  • Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States
  • Barnet Dulaney Perkins Eye Center — Phoenix, Arizona, United States
  • Associated Retina Consultants — Phoenix, Arizona, United States
  • Retinal Consultants of Arizona — Phoenix, Arizona, United States
  • California Retina Consultants — Bakersfield, California, United States
  • Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
  • The Retina Partners — Encino, California, United States
  • Jacobs Retina center at the Shiley eye Institute UCSD — La Jolla, California, United States
  • Jules Stein Eye Institute/ UCLA — Los Angeles, California, United States
  • N CA Retina Vitreous Assoc — Mountain View, California, United States
  • Retina Consultants, San Diego — Poway, California, United States
  • Retinal Consultants Med Group — Sacramento, California, United States
  • West Coast Retina Medical Group — San Francisco, California, United States
  • UCSF — San Francisco, California, United States
  • Orange County Retina Med Group — Santa Ana, California, United States
  • California Retina Consultants — Santa Barbara, California, United States
  • Southwest Retina Consultants — Durango, Colorado, United States
  • Eye Center of Northern CO — Fort Collins, Colorado, United States
  • Colorado Retina Associates, PC — Lakewood, Colorado, United States
  • Retina Group of New England — Waterford, Connecticut, United States
  • Florida Eye Microsurgical Inst — Boynton Beach, Florida, United States
  • National Ophthalmic Research Institute — Fort Myers, Florida, United States
  • Florida Eye Associates — Melbourne, Florida, United States
  • Retina Care Specialists — Palm Beach Gardens, Florida, United States
  • Retina Specialty Institute — Pensacola, Florida, United States
  • Fort Lauderdale Eye Institute — Plantation, Florida, United States
  • Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
  • Southern Vitreoretinal Assoc — Tallahassee, Florida, United States
  • Retina Associates of Florida, LLC — Tampa, Florida, United States
  • Southeast Retina Center — Augusta, Georgia, United States
  • Georgia Retina PC — Marietta, Georgia, United States
  • Illinois Retina Associates — Joliet, Illinois, United States
  • University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
  • Wolfe Eye Clinic — West Des Moines, Iowa, United States
  • Retina Associates — Lenexa, Kansas, United States
  • Retina Associates of Kentucky — Lexington, Kentucky, United States
  • Paducah Retinal Center — Paducah, Kentucky, United States
  • Maine Eye Center — Portland, Maine, United States
  • The Retina Care Center — Baltimore, Maryland, United States
  • Johns Hopkins Med — Baltimore, Maryland, United States
  • Retina Group of Washington — Chevy Chase, Maryland, United States
  • Retina Specialists — Towson, Maryland, United States
  • Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
  • Foundation for Vision Research — Grand Rapids, Michigan, United States
  • Associated Retinal Consultants — Royal Oak, Michigan, United States
  • VitreoRetinal Surgery, PLLC. — Minneapolis, Minnesota, United States
  • Midwest Vision Research Foundation — Chesterfield, Missouri, United States
  • The Retina Institute - Chesterfield — St Louis, Missouri, United States
  • Sierra Eye Associates — Reno, Nevada, United States
  • Envision Ocular, LLC — Bloomfield, New Jersey, United States
  • Retina Associates of NJ — Teaneck, New Jersey, United States
  • University of New Mexico — Albuquerque, New Mexico, United States
  • Long Is. Vitreoretinal Consult — Great Neck, New York, United States
  • Retina Assoc of Western NY — Rochester, New York, United States
  • Ophthalmic Consultants of Long Island — Rockville Centre, New York, United States
  • Retina Vit Surgeons/Central NY — Syracuse, New York, United States
  • Char Eye Ear &Throat Assoc — Charlotte, North Carolina, United States
  • Cincinnati Eye Institute — Cincinnati, Ohio, United States
  • The Cleveland Clinic Foundation — Cleveland, Ohio, United States
  • OSU Eye Physicians & Surgeons — Columbus, Ohio, United States
  • Retina Vitreous Center — Edmond, Oklahoma, United States
  • Retina Northwest — Portland, Oregon, United States
  • Oregon HSU — Portland, Oregon, United States
  • Mid Atlantic Retina - Wills Eye Hospital — Philadelphia, Pennsylvania, United States
  • Palmetto Retina Center — Florence, South Carolina, United States
  • Palmetto Retina Center, LLC — West Columbia, South Carolina, United States
  • Charles Retina Institute — Germantown, Tennessee, United States
  • Tennessee Retina PC — Nashville, Tennessee, United States
  • Texas Retina Associates — Arlington, Texas, United States
  • Austin Retina Associates — Austin, Texas, United States
  • Austin Clinical Research LLC — Austin, Texas, United States
  • Retina Consultants of Texas — Bellaire, Texas, United States
  • Texas Retina Associates — Fort Worth, Texas, United States
  • Med Center Ophthalmology Assoc — San Antonio, Texas, United States
  • Retina Consultants of Texas — The Woodlands, Texas, United States
  • Retina Associates of Utah, PLLC — Salt Lake City, Utah, United States
  • Rocky Mountain Retina — Salt Lake City, Utah, United States
  • Wagner Kapoor Institute — Virginia Beach, Virginia, United States
  • Pacific Northwest Retina — Silverdale, Washington, United States
  • Spokane Eye Clinical Research — Spokane, Washington, United States
  • Oftalmos — Capital Federal, Argentina
  • Centro Oftalmologico Dr. Charles S.A. — Ciudad Autonoma Buenos Aires, Argentina
  • Grupo Laser Vision — Rosario, Argentina
  • Eyeclinic Albury Wodonga — Albury, New South Wales, Australia
  • Eye and Retina Consultants — Hurstville, New South Wales, Australia
  • LKH-Univ.Klinikum Graz — Graz, Austria
  • Medizinische Universitat Wien — Vienna, Austria
  • UZ Leuven Gasthuisberg — Leuven, Belgium
  • Botelho Hospital da Visao — Blumenau, Santa Catarina, Brazil
  • Retina Clinic — São Paulo, São Paulo, Brazil
  • Universidade Federal de Sao Paulo - UNIFESPX — São Paulo, São Paulo, Brazil
  • Instituto da Visao IPEPO — São Paulo, São Paulo, Brazil
  • Hosp de Olhos de Sorocaba — Sorocaba, São Paulo, Brazil
  • Centre Retine Gallien — Bordeaux, France
  • Hopital de la croix rousse — Lyon, France
  • Centre Paradis Monticelli — Marseille, France
  • Hopital Lariboisiere — Paris, France
  • Fondation Rothschild — Paris, France
  • Universitatsklinikum Bonn — Bonn, Germany
  • Universitatsklinikum Koln — Cologne, Germany
  • Medizinische Universitat Lausitz ? Carl Thiem — Cottbus, Germany
  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde — Freiburg im Breisgau, Germany
  • Universitatsklinikum Hamburg-Eppendorf — Hamburg, Germany
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH — Ludwigshafen, Germany
  • LMU Klinikum der Universitat, Augenklinik — München, Germany
  • Augenabteilung am St. Franziskus-Hospital — Münster, Germany
  • Universitatsklinikum Munster — Münster, Germany
  • Knappschaftsklinikum Saar GmbH — Sulzbach, Germany
  • Universitatsklinikum Tubingen — Tübingen, Germany
  • Universitatsklinikum Ulm, Augenklinik und Poliklinik — Ulm, Germany
  • Rambam Medical Center — Haifa, Israel
  • Hadassah MC — Jerusalem, Israel
  • Meir Medical Center — Kfar Saba, Israel
  • Rabin MC — Petah Tikva, Israel
  • Kaplan Medical Center — Rehovot, Israel
  • Tel Aviv Sourasky MC — Tel Aviv, Israel
  • Ospedale Clinicizzato SS Annunziata — Chieti, Abruzzo, Italy
  • Policlinico di Bari — Bari, Apulia, Italy
  • Azienda Ospedaliero Universitaria "Ospedali Riuniti" Trieste-Ospedale Maggiore — Trieste, Friuli Venezia Giulia, Italy
  • Policlinico Universitario Agostino Gemelli — Rome, Lazio, Italy
  • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico — Rome, Lazio, Italy
  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena — Milan, Lombardy, Italy
  • Irccs Ospedale San Raffaele — Milan, Lombardy, Italy
  • Asst Fatebenefratelli Sacco — Milan, Lombardy, Italy
  • Azienda Ospedaliero Universitaria Ospedali Riuniti — Torrette - Ancona, The Marches, Italy
  • Azienda Ospedaliero-Universitaria Careggi — Florence, Tuscany, Italy
  • Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia — Perugia, Umbria, Italy
  • Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria — Negrar - Verona, Veneto, Italy
  • A.O. Universitaria S. Maria Della Misericordia Di Udine — Udine, Veneto, Italy
  • Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain
  • Hospital General de Catalunya — San Cugat Del Valles, Barcelona, Spain
  • Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain
  • Clinica Universitaria de Navarra — Pamplona, Navarre, Spain
  • Instituto Oftalmologico Fernandez Vega — Oviedo, Principality of Asturias, Spain
  • Oftalvist Valencia — Burjassot, Valencia, Spain
  • Centro de Oftalmologia Barraquer — Barcelona, Spain
  • Institut de la Macula i la retina — Barcelona, Spain
  • Hospital dos de maig — Barcelona, Spain
  • Hospital Universitari Vall d'Hebron — Barcelona, Spain
  • Hospital de la Arruzafa. Servicio de Oftalmologia — Córdoba, Spain
  • Clinica Baviera — Madrid, Spain
  • Universitatsspital Basel Augenklinik Klinik — Basel, Switzerland
  • Inselspital Universitaetsklinik fuer Augenheilkunde;Marie-Colinet-Haus — Bern, Switzerland
  • Vista Klinik Ophthalmologische Klinik — Binningen, Switzerland
  • Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital — Lausanne, Switzerland
  • Stadtspital Triemli Ophthalmologische Klinik — Zurich, Switzerland
  • Changhua Christian Hospital — Changhua, Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Chang Gung Medical Foundation - Linkou — Taoyuan, Taiwan
  • National Taiwan University Hospital — Zhongzheng Dist., Taiwan
  • Hacettepe University Medical Faculty — Ankara, Turkey (Türkiye)
  • Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye)
  • Ankara Etlik City Hospital — Ankara, Turkey (Türkiye)
  • Beyoglu Goz Training and Research Hospital — Istanbul, Turkey (Türkiye)
  • Kocaeli University Medical Faculty — Kocaeli, Turkey (Türkiye)
  • Bristol Eye Hospital — Bristol, United Kingdom
  • Royal Liverpool University Hospital — Liverpool, United Kingdom
  • Moorfields Eye Hospital NHS Foundation Trust — London, United Kingdom
  • Central Middlesex Hospital — London, United Kingdom
  • Kings College Hospital NHS Foundation Trust — London, United Kingdom
  • Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom
  • Sunderland Eye Infirmary — Sunderland, United Kingdom
  • Royal Wolverhampton hospital — Wolverhampton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record