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NCT03917472 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 517
- Enrollment target
NCT03917472: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03917472 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 517 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03917472, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 517 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).
Primary Outcome
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used
Interventions
- DRUG Aflibercept
- DRUG Brolucizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2019-07-17 |
| Est. Completion | 2021-03-24 |
| Phase | Phase 3 |
What the finished NCT03917472 record still lists
NCT03917472 is an interventional study that assigns participants to a tested intervention. The registered 517 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 (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Aflibercept is the first listed.
NCT03917472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03917472 about?
NCT03917472 is a clinical study titled "Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema". The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).
What is the current status of trial NCT03917472?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 517 participants. The study started on 2019-07-17. Estimated completion is 2021-03-24.
What interventions are being tested in trial NCT03917472?
The interventions under investigation include: Aflibercept (DRUG), Brolucizumab (DRUG).
Who is sponsoring clinical trial NCT03917472?
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 NCT03917472's enrollment target sits among peer trials
517 724th of 2000 higher than 1,277 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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