A Clinical Trial to Assess the Long-Term Safety and Tolerability of a New Eye Implant to Give Ranibizumab to Patients with Neovascular Age-Related Macular Degeneration (Portal)

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

  • Age-Related Macular Degeneration
Trial Status:

Recruiting

This trial runs in
Countries
  • Argentina
  • Australia
  • United States
Trial Identifier:

NCT03683251 GR40549

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in patients 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT03683251 , GR40549 , 2020-004427-16 Trial Identifier
      All Gender
      ≥ 50 Years Age
      No Healthy Volunteers

      How does the Portal clinical trial work?
      This is a US-only clinical trial recruiting people who have a type of eye disease called ‘neovascular age-related macular degeneration’ or wet AMD, and have already taken part in either the phase II clinical trial called LADDER or the phase III clinical trial called Archway.

      How do I take part in this clinical trial?
      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor.

      If you have already taken part in either the phase II clinical trial LADDER or phase III clinical trial Archway, the clinical trial doctor will give you all the information you need to make your decision for continuing your treatment. The treatment will start on the same day as your final visit if you are already taking part in the LADDER clinical trial https://clinicaltrials.gov/ct2/show/NCT02510794 or will start at the Week 96 visit if you are taking part in the Archway clinical trial https://clinicaltrials.gov/ct2/show/NCT03677934.

      Before starting the clinical trial, you will be told about any risks and benefits of taking part in the study and what other treatments are available so that you may decide if you still want to take part. If you are female, and not currently pregnant but able to become pregnant, you will need to take contraceptive medication while you are taking part in the clinical trial for safety purposes.

      What treatment will I be given if I join this clinical trial?
      If you were given an eye implant in the LADDER or Archway clinical trials, you will continue to use the implant and will be given refills of the treatment, every 6 months for about 3 years (this is 6 refills). If you were given an injection of ranibizumab directly into your eye in either of the previous trials, you will be given the implant into your eye when you enter this clinical trial. After the implant is in place, it will be refilled with the same medicine every 6 months for approximately 3 years (this is 6 refills). The eye implant is a new device that the FDA has not approved. The implant is slightly bigger than a grain of rice.

      How often will I be seen in follow-up appointments, and for how long?
      If you take part in this clinical trial, you will need to go to the clinical trial site every 8 weeks for about 3 years to have your vision checked, eye exams, health assessments and blood tests to look at how your body is responding to the ranibizumab treatment (and, if you are female, you will have a pregnancy test at specified visits). At the clinical trial site you will also be asked to complete a survey about your eye sight. Patients who have been given an eye implant as part of this clinical trial will need to go to the clinical trial site for two extra visits on Day 2 and Day 7 after the surgery, to check the safety of the implant.

       

      What happens if I’m unable to take part in this clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other treatments that you can be given or other clinical trials that you may be able to take part in. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on this page or follow this link to ClinicalTrials.gov

      Trial-identifier: NCT03683251

      Trial Summary

      This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in patients 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT03683251 , GR40549 , 2020-004427-16 Trial Identifier
      PDS Implant with Ranibizumab 100 mg/mL Treatments
      Neovascular Age-Related Macular Degeneration Condition
      Official Title

      A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)

      Eligibility Criteria

      All Gender
      ≥ 50 Years Age
      No Healthy Volunteers
      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
        - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures,

      Patients 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
      • 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"

      Substudy

      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 patients 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

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