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NCT03386474 · ClinicalTrials.gov registry record · Phase 3
Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
NCT03386474: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03386474 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 151 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03386474, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
Study 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).
Primary Outcome
Number of participants with ocular and non-ocular treatment emergent events with the new formulation brolucizumab 6 mg in this extension trial up to week 24 vs. the corresponding last 6 months of brolucizumab treatment in the Core trial \>= 2%. Safety assessment of the new formulation brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding Core safety data. Missing brolucizumab data were imputed using last observation carried forward (LOCF).
Interventions
- DRUG Brolucizumab 6 mg
- DRUG Aflibercept 2 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2018-09-06 |
| Phase | Phase 3 |
What the finished NCT03386474 record still lists
NCT03386474 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Brolucizumab 6 mg is the first listed.
NCT03386474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03386474 about?
NCT03386474 is a clinical study titled "Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD". 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 a...
What is the current status of trial NCT03386474?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2018-01-15. Estimated completion is 2018-09-06.
What interventions are being tested in trial NCT03386474?
The interventions under investigation include: Brolucizumab 6 mg (DRUG), Aflibercept 2 mg (DRUG).
Who is sponsoring clinical trial NCT03386474?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03386474's enrollment target sits among peer trials
151 1517th of 2000 higher than 482 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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