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Trial record 1 of 1 for:    GR40549
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Extension Study for the Port Delivery System With Ranibizumab (Portal) (Portal)

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ClinicalTrials.gov Identifier: NCT03683251
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) 100 mg/mL with refills administered every 24 weeks (Q24W) for approximately 144 weeks in participants with neovascular age-related macular degeneration who have completed either Phase II Study GX28228 (Ladder) or Phase III Study GR40548 (Archway).

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: PDS Implant with Ranibizumab 100 mg/mL Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: PDS Implant Cohort 1
Participants with PDS Implant from Study GX28228 Treated with Refills of 100 mg/mL Ranibizumab Q24W
 Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm
Experimental: PDS Implant Cohort 2
Participants with PDS Implant From Study GR40548 Treated with Refills of 100 mg/mL Ranibizumab Q24W
 Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm
Experimental: PDS Implant Cohort 3
Participants in the Intravitreal Ranibizumab Arm of Study GX28228 who will Receive the PDS Implant Upon Study Entry and Refills of 100 mg/mL Ranibizumab Q24W
 Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm
Experimental: PDS Implant Cohort 4
Participants in the Intravitreal Ranibizumab Arm of Study GR40548 who will Receive the PDS Implant Upon Study Entry and Refills of 100 mg/mL Ranibizumab Q24W
 Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs) [ Time Frame: Baseline up to Week 144 ]
  2. Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs) [ Time Frame: Baseline up to Week 144 ]
  3. Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Initial Implantation) and Follow-Up Period (>37 days After Implantation Surgery) for Participants who Receive the PDS Implant in the Study [ Time Frame: Baseline up to Week 144 ]

Secondary Outcome Measures :
  1. Change in Best-Corrected Visual Acuity (BCVA) Score from Baseline Over Time, as Assessed using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters [ Time Frame: Baseline up to Week 144 ]

    ETDRS = Early Treatment Diabetic Retinopathy Study

    A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.


  2. Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time [ Time Frame: Baseline up to Week 144 ]
  3. Percentage of Participants with BCVA Score of 34 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time [ Time Frame: Baseline up to Week 144 ]
  4. Percentage of Participants with BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better over Time [ Time Frame: Baseline up to Week 144 ]
  5. Change from Baseline in Center Point Thickness Over Time [ Time Frame: Baseline up to Week 144 ]
  6. Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, Fourth, and Fifth Refill Interval [ Time Frame: Weeks 16 to Week 136 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 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"
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683251


Contacts
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Contact: Reference Study ID Number: GR40549 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03683251    
Other Study ID Numbers: GR40549
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents