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

Recruiting now · Phase 3

Conditions studied: Neovascular Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT03683251

Run by

Hoffmann-La Roche

People needed

1000

Starts

2018-09-20

Expected to finish

2029-12-31

Last updated by the study team

2026-07-31

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hopital Lariboisiere — Paris, France (enrolling)
• Augenabteilung am St. Franziskus-Hospital — Münster, Germany (enrolling)
• Botelho Hospital da Visao — Blumenau, Santa Catarina, Brazil (enrolling)
• Centre Paradis Monticelli — Marseille, France (enrolling)
• Universitätsklinikum Freiburg, Klinik für Augenheilkunde — Freiburg im Breisgau, Germany (enrolling)
• LMU Klinikum der Universitat, Augenklinik — München, Germany (enrolling)
• Grupo Laser Vision — Rosario, Argentina (enrolling)
• Medizinische Universitat Wien — Vienna, Austria (enrolling)
• Instituto da Visao IPEPO — São Paulo, São Paulo, Brazil (enrolling)
• Hopital de la croix rousse — Lyon, France (enrolling)
• Universitatsklinikum Koln — Cologne, Germany (enrolling)
• Medizinische Universitat Lausitz ? Carl Thiem — Cottbus, Germany (enrolling)
• Universitatsklinikum Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Klinikum der Stadt Ludwigshafen am Rhein gGmbH — Ludwigshafen, Germany (enrolling)
• Oftalmos — Capital Federal, Argentina (enrolling)
• Centro Oftalmologico Dr. Charles S.A. — Ciudad Autonoma Buenos Aires, Argentina (enrolling)
• Eye and Retina Consultants — Hurstville, New South Wales, Australia (enrolling)
• LKH-Univ.Klinikum Graz — Graz, Austria (enrolling)
• Retina Clinic — São Paulo, São Paulo, Brazil (enrolling)
• Universidade Federal de Sao Paulo - UNIFESPX — São Paulo, São Paulo, Brazil (enrolling)
• Hosp de Olhos de Sorocaba — Sorocaba, São Paulo, Brazil (enrolling)
• Centre Retine Gallien — Bordeaux, France (enrolling)
• Fondation Rothschild — Paris, France (enrolling)
• Universitatsklinikum Bonn — Bonn, Germany (enrolling)
• Universitatsklinikum Munster — Münster, Germany (enrolling)

Full record on ClinicalTrials.gov

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