Phase 3
Completed N=150
Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD
Source: ClinicalTrials.gov NCT03386474 ↗Enrolled (actual)
150
Serious AEs
9.3%
Results posted
Apr 2020
Primary outcomePrimary: Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events — 20; 25; 51; 50 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this extension study was to assess the safety and efficacy of the new formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who received brolucizumab in the core trial CRTH258A2301 (also known as CRTH258-C002). The medical condition treated in the core and extension trials was neo-vascular age-related macular degeneration (nAMD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events |
20; 25; 51; 50 | — |
| SECONDARY Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit |
2; 0; 2; 4; 0; 4 | — |
| SECONDARY Change in BCVA From Extension Baseline at Each Post-baseline Visit |
-1.3; 0.5; -0.5; -1.7; -0.4; -1.2 | — |
| SECONDARY Patients With Positive q12w Treatment Status at Week 20 |
63.3; 63.1; 63.3 | — |
| SECONDARY Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit |
-19.2; -17.5; -18.5; -6.3; -18.9; -11.6 | — |
| SECONDARY Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status for Brolucuzumab 6 mg in Extension |
54 | — |
Eligibility Criteria
Inclusion Criteria
- Sign written informed consent
- Completed the core study, CRTH258A2301, also known as CRTH258-C002 as defined by assessments at Visit 26/Week 96 within ≤12 weeks of the baseline.
Exclusion Criteria
- Patient discontinued the treatment or the core study prematurely at any time
- Patient received standard of care treatment for nAMD after completion of the core study
- Pregnant or nursing women and women of child-bearing potential
- Stroke or MI (myocardial infarction) within 3 months of the baseline extension visit
Data sourced from ClinicalTrials.gov (NCT03386474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.