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NCT04278417 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
A Phase 3 study of Proliferative Diabetic Retinopathy, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 689
- Enrollment target
- 20
- Study locations
NCT04278417 is a Phase 3 study of Proliferative Diabetic Retinopathy that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 689 participants, above the 79-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (772% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT04278417, a Phase 3 study of Proliferative Diabetic Retinopathy, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 689 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.
Conditions Studied
Interventions
- BIOLOGICAL Brolucizumab 6 mg
- PROCEDURE Panretinal photocoagulation laser
Study Locations (20)
Florida
- Advanced Research LLC - Deerfield Beach
- Rand Eye Institute - Deerfield Beach
- Pinnacle Research Institute - Fort Lauderdale
- National Ophthalmic Research Institute - Fort Myers
- Florida Retina Institute - Jacksonville
- Blue Oc Clin Res at Palm Bch Eye Ct - Lakeland
- MedEye Associates - Miami
- Florida Retina Institute - Orlando
- Eye Center of North Florida - Panama City
- Fort Lauderdale Eye Institute - Plantation
California
- Retina- Vitreous Assoc Medical Group - Beverly Hills
- Retina Consultants of Orange County - Fullerton
- Salehi Retina Institute - Huntington Beach
- Retina Consultants of Southern California - Redlands
- Premiere Practice Management LLC - Torrance
- Lundquist Inst BioMed at Harbor - Torrance
- Miramar Eye Specialists - Ventura
Arizona
- Retina Associates SW - Tucson
Illinois
- Retina Associates - Elmhurst
Indiana
- Midwest Eye Institute - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 689 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2024-08-19 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04278417
The ClinicalTrials.gov registry entry for NCT04278417 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 689 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 79-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (772% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Proliferative Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions - of which Brolucizumab 6 mg is the first listed.
NCT04278417 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04278417 about?
NCT04278417 is a clinical study titled "Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy". The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the chang...
What is the current status of trial NCT04278417?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 689 participants. The study started on 2020-11-19. Estimated completion is 2024-08-19.
What conditions does trial NCT04278417 study?
This clinical trial studies the following conditions: Proliferative Diabetic Retinopathy.
What interventions are being tested in trial NCT04278417?
The interventions under investigation include: Brolucizumab 6 mg (BIOLOGICAL), Panretinal photocoagulation laser (PROCEDURE).
Who is sponsoring clinical trial NCT04278417?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04278417 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.