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NCT03481634 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
A Phase 3 study of Diabetic Macular Edema, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 566
- Enrollment target
- 20
- Study locations
NCT03481634 is a Phase 3 study of Diabetic Macular Edema that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 566 participants, below the 3,785-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT03481634, a Phase 3 study of Diabetic Macular Edema, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 566 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Conditions Studied
Interventions
- DRUG Aflibercept
- DRUG Brolucizumab
Study Locations (20)
California
- Novartis Investigative Site - Beverly Hills
- Novartis Investigative Site - La Jolla
- Novartis Investigative Site - Mountain View
- Novartis Investigative Site - Santa Barbara
Florida
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Pensacola
- Novartis Investigative Site - Stuart
Illinois
- Novartis Investigative Site - Urbana
- Novartis Investigative Site - Wheaton
Indiana
- Novartis Investigative Site - Indianapolis
- Novartis Investigative Site - New Albany
Kansas
- Novartis Investigative Site - Leawood
- Novartis Investigative Site - Lenexa
Massachusetts
- Novartis Investigative Site - Springfield
- Novartis Investigative Site - Stoneham
Arizona
- Novartis Investigative Site - Phoenix
Colorado
- Novartis Investigative Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 566 participants |
| Start Date | 2018-07-23 |
| Est. Completion | 2021-10-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03481634
The ClinicalTrials.gov registry entry for NCT03481634 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 566 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,785-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (85% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Aflibercept is the first listed.
NCT03481634 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03481634 about?
NCT03481634 is a clinical study titled "Study of 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 in treatment of patients with visual impairment due to diabetic macular edema (DME).
What is the current status of trial NCT03481634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 566 participants. The study started on 2018-07-23. Estimated completion is 2021-10-18.
What conditions does trial NCT03481634 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT03481634?
The interventions under investigation include: Aflibercept (DRUG), Brolucizumab (DRUG).
Who is sponsoring clinical trial NCT03481634?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03481634 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
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CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
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Read our methodology - how this data is sourced, computed, and verified.
Related
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