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

NCT04278417 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 689

Last updated 2025-10-16

Study results available
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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

  • Proliferative Diabetic Retinopathy

Interventions

BIOLOGICAL

Brolucizumab 6 mg

3 x q6w loading injections, followed by q12w maintenance through Week 90

PROCEDURE

Panretinal photocoagulation laser

initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2023-10-30
Completion
2024-08-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • China
  • India
  • Japan
  • Mexico
  • Philippines
  • Puerto Rico
  • Russia
  • South Korea
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04278417 on ClinicalTrials.gov