NCT04278417

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

A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 689 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase III, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to Panretinal photocoagulation (PRP) in subjects with Proliferative diabetic retinopathy (PDR). Subjects who consented underwent screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria. Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of the following treatments: Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks, and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens. PRP: initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment (may split into 2-4 sessions) as needed up to Week 90. Visits occurred every 6 weeks throughout the study, regardless of treatment or not.

Conditions

• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-19
• Primary completion: 2023-10-30
• Completion: 2024-08-19
• First posted: 2020-02-20
• Last updated: 2025-10-16
• Results posted: 2024-08-20

Locations

120 sites across 16 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, India, Japan, Mexico, Philippines, Puerto Rico, Russia, South Korea, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study