A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration

Sponsor
Hoffmann-La Roche
Study ID
NCT05126966
Phase
PHASE3
Status
Withdrawn

Conditions

  • Neovascular Age-Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Ranibizumab will be administered at a dose of 100 mg/mL delivered via the PDS.
  • Aflibercept — DRUG
    Aflibercept will be administered at a dose of 2 mg in the study eye per treat-and-extend. The decision to extend, maintain, or reduce the interval until next treatment will be per investigator judgment
  • Port Delivery System with ranibizumab (PDS) — DEVICE
    PDS is an investigation intraocular drug delivery device designed to continuously deliver anti-VEGF therapy.

Study Details

This study will evaluate the effectiveness and safety of a 36-week refill regimen for the Port Delivery System with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per treat-and-extend (aflibercept T\&E) in subjects with neovascular (wet) age-related macular degeneration (nAMD).

Key Dates

Start date
Dec 29, 2023
Status verified
Jan 2024
Primary completion
Jan 31, 2025
Completion
Jan 30, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    Subjects will have the implant (filled intra-operatively prior to implantation with approximately 20 µL of the 100-mg/mL formulation of ranibizumab \[approximately 2-mg dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Subjects will have their implant refilled with ranibizumab at weeks 36 and 72.
  • Active Comparator: Aflibercept
    Subjects will receive intravitreal injections of aflibercept (2mg) administered in the study eye per treat-and-extend. The decision to extend, maintain, or reduce the interval until next treatment will be per investigator judgment.

Primary Outcome Measure

Change from baseline in BCVA score at week 80 as assessed using the ETDRS visual acuity chart at a starting distance of 4 meters [ Time Frame: From baseline up to 80 weeks ]

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