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Trial record 2 of 3 for:    ARCHWAY

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683251
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE September 25, 2018
Last Update Posted Date October 29, 2020
Actual Study Start Date  ICMJE September 20, 2018
Estimated Primary Completion Date September 19, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs) [ Time Frame: Baseline up to Week 144 ]
  • Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs) [ Time Frame: Baseline up to Week 144 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs) [ Time Frame: Baseline up to Week 144 ]
  • Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs), Including PDS-Associated AEs [ Time Frame: Baseline up to Week 144 ]
  • Incidence, Severity, and Duration of PDS-Associated Ocular AEs During the Postoperative Period (Up to 4 Weeks of Initial Implantation) and Follow-Up Period (>4 Weeks After Implantation Surgery) for Participants who Receive the Implant in the Study [ Time Frame: Baseline up to Week 144 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
  • 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.
  • Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time [ Time Frame: Baseline up to Week 144 ]
  • Percentage of Participants with BCVA Score of 38 Letters (of 20/200 Approximate Snellen Equivalent) or Worse over Time [ Time Frame: Baseline up to Week 144 ]
  • 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 ]
  • Change from Baseline in Center Point Thickness Over Time [ Time Frame: Baseline up to Week 144 ]
  • Percentage of Participants who Undergo Supplemental Treatment with Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, Fourth, and Fifth Refill-exchange Interval [ Time Frame: Weeks 16 to Week 136 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • 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 ]
    EDTRS = 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.
  • Percentage of Participants who Lose <15, <10, or <5 Letters in BCVA Score from Baseline Over Time [ Time Frame: Baseline up to Week 144 ]
  • 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 ]
  • 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 ]
  • Change from Baseline in Center Point Thickness Over Time [ Time Frame: Baseline up to Week 144 ]
  • Percentage of Participants who Undergo Rescue Treatment of Intravitreal Ranibizumab Before the First, Second, Third, Fourth, and Fifth Refill Interval [ Time Frame: Weeks 16 to Week 136 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study for the Port Delivery System With Ranibizumab (Portal)
Official Title  ICMJE 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)
Brief Summary This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) 100 mg/mL with refill-exchanges administered every 24 weeks (Q24W) or every 36 weeks (Q36W) for approximately 144 weeks in participants with neovascular age-related macular degeneration who have completed either Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway) or Phase IIIb Study WR42221 (Velodrome).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-Related Macular Degeneration
Intervention  ICMJE Drug: PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm
Study Arms  ICMJE
  • Experimental: PDS Implant Cohort 1

    Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W.

    Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.

    Intervention: Drug: PDS Implant with Ranibizumab 100 mg/mL
  • Experimental: PDS Implant Cohort 2

    Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W.

    Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.

    Intervention: Drug: PDS Implant with Ranibizumab 100 mg/mL
  • Experimental: PDS Implant Cohort 3

    Participants in the intravitreal ranibizumab arm of Study GX28228 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W.

    Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.

    Intervention: Drug: PDS Implant with Ranibizumab 100 mg/mL
  • Experimental: PDS Implant Cohort 4

    Participants in the intravitreal ranibizumab arm of Study GR40548 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W.

    Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.

    Intervention: Drug: PDS Implant with Ranibizumab 100 mg/mL
  • Experimental: PDS Implant Cohort 5
    Participants from Study WR42221 who completed Week 24 but were not eligible to be randomized within WR42221 and who will be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W
    Intervention: Drug: PDS Implant with Ranibizumab 100 mg/mL
  • Experimental: PDS Implant Cohort 6
    Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W
    Intervention: Drug: PDS Implant with Ranibizumab 100 mg/mL
  • Experimental: PDS Implant Cohort 7
    Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W
    Intervention: Drug: PDS Implant with Ranibizumab 100 mg/mL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2020)
1000
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2018)
500
Estimated Study Completion Date  ICMJE September 19, 2025
Estimated Primary Completion Date September 19, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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"
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03683251
Other Study ID Numbers  ICMJE GR40549
2020-004427-16 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical 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).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP