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NCT05126966: Diagrid

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

Withdrawn Phase 3 Last updated 18 January 2024
What this trial tests

Phase 3 trial testing Ranibizumab in Neovascular Age-Related Macular Degeneration. Withdrawn.

Timeline
29 December 2023
Primary endpoint
31 January 2025
30 January 2026

Quick facts

Lead sponsorHoffmann-La Roche
PhasePhase 3
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Start date29 December 2023
Primary completion31 January 2025
Estimated completion30 January 2026
Sites10 locations across Denmark, Hong Kong, Greece, Argentina, Thailand, Portugal, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

50 and older, any sex, with Neovascular Age-Related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Alternative Routes of Administration for Therapeutic Antibodies-State of the Art.
    Pitiot A, Heuzé-Vourc'h N, Sécher T. · · 2022 · cited 45× · PMID 36134952 · DOI 10.3390/antib11030056
  2. High-efficiency base editing in the retina in primates and human tissues.
    Muller A, Sullivan J, Schwarzer W, Wang M, et al · · 2025 · cited 34× · PMID 39779923 · DOI 10.1038/s41591-024-03422-8
  3. Developing and validating a multivariable prediction model which predicts progression of intermediate to late age-related macular degeneration-the PINNACLE trial protocol.
    Sutton J, Menten MJ, Riedl S, Bogunović H, et al · · 2023 · cited 26× · PMID 35614343 · DOI 10.1038/s41433-022-02097-0
  4. TBC1D32 variants disrupt retinal ciliogenesis and cause retinitis pigmentosa.
    Bocquet B, Borday C, Erkilic N, Mamaeva D, et al · · 2023 · cited 14× · PMID 37768732 · DOI 10.1172/jci.insight.169426
  5. An Update on Strategies to Deliver Protein and Peptide Drugs to the Eye.
    Boddu SHS, Acharya D, Hala V, Jani H, et al · · 2023 · cited 12× · PMID 37810716 · DOI 10.1021/acsomega.3c02897
  6. Clinical Trials and Future Outlooks of the Port Delivery System with Ranibizumab: A Narrative Review.
    Lowater SJ, Grauslund J, Subhi Y, Vergmann AS. · · 2024 · cited 10× · PMID 38055121 · DOI 10.1007/s40123-023-00843-5
  7. Establishing Fully-Automated Fundus-Controlled Dark Adaptometry: A Validation and Retest-Reliability Study.
    Oertli JM, Pfau K, Scholl HPN, Jeffrey BG, et al · · 2023 · cited 9× · PMID 38112496 · DOI 10.1167/tvst.12.12.18
  8. Deep Learning-Based Clustering of OCT Images for Biomarker Discovery in Age-Related Macular Degeneration (PINNACLE Study Report 4).
    Holland R, Kaye R, Hagag AM, Leingang O, et al · · 2024 · cited 8× · PMID 39139544 · DOI 10.1016/j.xops.2024.100543

Verify or expand the search:

Other trials of Ranibizumab

Trials testing the same drug.

Other recruiting trials for Neovascular Age-Related Macular Degeneration

Currently open trials in the same condition.

Other Hoffmann-La Roche trials

Trials by the same sponsor.

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