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Completed

NCT Number: NCT03677934

A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Barnet Dulaney Perkins Eye Center, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥50 years, at time of signing Informed Consent Form
  • Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit
  • Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
  • Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
  • Best-corrected visual acuity (BCVA) of 34 letters or better

Exclusion criteria

  • Subfoveal fibrosis or subfoveal atrophy in study eye
  • Subretinal hemorrhage that involves the center of the fovea in study eye
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
  • Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
  • Previous intraocular device implantation in study eye
  • Previous laser (any type) used for AMD treatment in study eye
  • Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
  • Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye
  • CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye
  • 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 participant at high risk of treatment complications in the opinion of the investigator
  • Current systemic treatment for a confirmed active systemic infection
  • Chronic use of oral corticosteroids
  • Active cancer within 12 months of randomization
  • Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)

Treatment and study plan

PDS Implant filled with 100 mg/mL Ranibizumab

Drug

Will be administered as per the schedule described in individual arm.

Intravitreal Injections of 10 mg/mL Ranibizumab

Drug

Will be administered as per the schedule described in individual arm.

Primary outcomes

  1. Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters

    Time frame: Baseline, and the average of Week 36 and Week 40

    The primary efficacy endpoint is the change in BCVA score from baseline averaged over Weeks 36 and 40 with BCVA assessed using the ETDRS chart at a starting distance of 4 meters. ETDRS = Early Treatment Diabetic Retinopathy Study.

    The primary objective is to determine the NI and equivalence between the two treatment groups, as measured by the primary efficacy endpoint with a NI margin of 4.5 letters and equivalence margins of ± 4.5 letters.

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

Secondary outcomes

  1. Change From Baseline in BCVA Score Averaged Over Week 60 and Week 64

    Time frame: Baseline, Week60, Week 64

  2. Change From Baseline in BCVA Score Over Time

    Time frame: Baseline up to Week 96

  3. Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse at the Average Over Week 36 and Week 40

    Time frame: Baseline, and the average of Week 36 and Week 40

  4. Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time

    Time frame: Baseline up to Week 96

  5. Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better at the Average Over Week 36 and Week 40

    Time frame: Baseline, and the average of Week 36 and Week 40

  6. Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Over Time

    Time frame: Baseline up to Week 96

  7. Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40

    Time frame: Baseline, and the average of Week 36 and Week 40

  8. Percentage of Participants Who Lose <10 or <5 Letters in BCVA Score From Baseline Over Time

    Time frame: Baseline up to Week 96

  9. Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline to the Average Over Week 36 and Week 40

    Time frame: Baseline up to Week 40

  10. Percentage of Participants Who Gain ≥0 Letters in BCVA Score From Baseline Over Time

    Time frame: Baseline up to Week 96

  11. Change From Baseline in Center Point Thickness (CPT) at Week 36

    Time frame: Baseline to Week 36

  12. Change From Baseline in CPT Over Time

    Time frame: Baseline up to Week 96

  13. Percentage of Participants in the PDS Implant Arm Who Undergo Supplemental Treatment With Intravitreal Ranibizumab 0.5 mg Before the First, Second, Third, and Fourth Fixed Refill-Exchange Intervals

    Time frame: Day 1 to Week 24, Week 25 to Week 48, Week 49 to Week 72, Week73 to Week 96

  14. Percentage of Participants in the PDS Implant Arm Who Undergo a Supplemental Treatment That Requires Subsequent Additional Supplemental Treatments During the Study

    Time frame: Week 16 to Week 92

  15. Percentage of Participants With Ocular and Systemic (Non-Ocular) AEs

    Time frame: Randomization to Week 96

  16. Percentage of Participants With Adverse Events of Special Interest

    Time frame: Randomization to Week 96

    Percentage of Participants with Adverse Events of Special Interest

  17. Observed Serum Ranibizumab Concentrations at Specified Timepoints

    Time frame: Randomization to Week 96

  18. Estimated PK Parameter Values AUC0-6M

    Time frame: Randomization to Week 96

    AUC0-6M = Area Under the Concentration-Time Curve From 0 to 6 Months

  19. Estimated PK Parameter Value t1/2 After PDS Implant Insertion

    Time frame: Randomization to Week 96

    Apparent terminal half-life

  20. Estimated PK Parameter Value Cmin

    Time frame: Randomization to Week 96

    Cmin = Minimum Serum Concentration

  21. Estimated PK Parameter Value Cmax

    Time frame: Randomization to Week 96

    Cmax = Maximum Serum Concentration

  22. Baseline Prevalence and Incidence of Treatment-Emergent ADA

    Time frame: Randomization to Week 96

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration

Acronym: Archway

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 19, 2018
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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