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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 151 participants.

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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).

Interventions

  • DRUG Brolucizumab 6 mg
  • DRUG Aflibercept 2 mg

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2018-01-15
Est. Completion 2018-09-06
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT03386474

The ClinicalTrials.gov registry entry for NCT03386474 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Brolucizumab 6 mg is the first listed.

NCT03386474 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.