Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

NCT04278417 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 689 participants
Start Date 2020-11-19
Est. Completion 2024-08-19
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 689 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04278417 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04278417?

The interventions under investigation include: Brolucizumab 6 mg (BIOLOGICAL), Panretinal photocoagulation laser (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04278417?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial