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NCT03930641

Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration

Completed Phase 3 Results posted Last updated 5 January 2021
What this trial tests

Phase 3 trial testing RTH258 in Neovascular Age Related Macular Degeneration in 34 participants. Completed in 2 July 2019.

Timeline
23 May 2019
Primary endpoint
2 July 2019
2 July 2019

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment34
Start date23 May 2019
Primary completion2 July 2019
Estimated completion2 July 2019
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — 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.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration Primary · Up to Day 31

The safety is defined as the incidence of ocular and non-ocular adverse events

Adverse Events
GroupValue95% CI
RTH2580
Deaths
GroupValue95% CI
RTH2580

Sponsor's own description

This was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.

Publications & conference data

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

  1. Evolution of <i>Escherichia coli</i> Expression System in Producing Antibody Recombinant Fragments.
    Sandomenico A, Sivaccumar JP, Ruvo M. · · 2020 · cited 70× · PMID 32878291 · DOI 10.3390/ijms21176324
  2. Recent Advances in Age-Related Macular Degeneration Therapies.
    Fabre M, Mateo L, Lamaa D, Baillif S, et al · · 2022 · cited 68× · PMID 36014339 · DOI 10.3390/molecules27165089

Verify or expand the search:

Other recruiting trials for Neovascular Age Related Macular Degeneration

Currently open trials in the same condition.

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03930641.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing