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, multicenter, phase III study assessing the efficacy and safety of brolucizumab 6 mg compared to panretinal photocoagulation laser in patients with proliferative diabetic retinopathy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200194

Enrollment

Registered

2020-11-10

Start date

2021-01-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative diabetic retinopathy proliferative diabetic retinophathy, retinal neovascularization, anti-VEGF, brolucizumab, intravitreal injection, panretinal photocoagulation

Interventions

Experimental: Brolucizumab Arm (Intra-vitreal injection), Active Comparator: Panretinal photocoagulation laser Arm (laser)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent must be obtained prior to participation - Able to complete adequate fundus photographs and retinal images - Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening - DM treatment stable for at least 3 months - PDR diagnosis with no previous PRP treatment in the study eye

Exclusion criteria

Exclusion criteria: - Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment. - Presence of diabetic macular edema in the study eye Active infection or inflammation in the study eye - Uncontrolled glaucoma (IOP greater than 25 mmHg) - Intravitreal anti-VEGF treatment within 6 months - Treatment with intraocular corticosteroids - End stage renal disease requiring dialysis or kidney transplant - Uncontrolled blood pressure - Systemic anti-VEGF therapy at any time Other protocol-defined inclusion/exclusion criteria may apply"

Design outcomes

Primary

Measure	Time frame
Change from Baseline in BCVA, to demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity at Week 54	—

Countries

Argentina, Australia, Brazil, Canada, Chile, China, India, Japan, Mexico, Philippines, Rep Korea, Russia, Taiwan, Turkey, USA

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026