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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
Phase 3 trial testing Ranibizumab in Neovascular Age-Related Macular Degeneration. Withdrawn.
31 January 2025
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 29 December 2023 |
| Primary completion | 31 January 2025 |
| Estimated completion | 30 January 2026 |
| Sites | 10 locations across Denmark, Hong Kong, Greece, Argentina, Thailand, Portugal, Spain |
Drugs / interventions tested
- Ranibizumab — full drug profile →
- Aflibercept (AFLIBERCEPT) — full drug profile →
- Port Delivery System with ranibizumab (PDS)
Conditions studied
- Neovascular Age-Related Macular Degeneration — all drugs for Neovascular Age-Related Macular Degeneration →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05126966
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ranibizumab
Trials testing the same drug.
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- NCT06176352 — A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Path · Phase 3 · active not recruiting
- NCT05480293 — This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab · Phase 3 · unknown
- NCT05576792 — A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in · completed
Other recruiting trials for Neovascular Age-Related Macular Degeneration
Currently open trials in the same condition.
- NCT06491914 — A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related · Phase 3 · active not recruiting
- NCT06223958 — Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects Wi · Phase 3 · active not recruiting
- NCT03683251 — Extension Study for the Port Delivery System With Ranibizumab (Portal) · Phase 3 · recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
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- NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05126966 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 18 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05126966.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing